Cambridge, M.A., November 7, 2023. New data from across Sanofi’s oncology and rare blood disorders portfolios will be featured in 25 clinical research presentations, including seven oral presentations, at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place December 9-12, 2023 in San Diego. These data demonstrate our commitment to scientific innovation and the potential of our investigational and approved therapies to address unmet needs across a spectrum of hematologic conditions with limited treatment options.
Brian Foard
Head, Specialty Care North America
“The spectrum of data Sanofi will present at ASH has the potential to reframe the possibilities for millions of patients living with hematologic conditions. New data for ALTUVIIIO, a first-in-class, high-sustained factor VIII replacement therapy, demonstrate our ambition to change treatment expectations for adults and children living with hemophilia A. Additionally, we continue to explore Sarclisa in combination with standard-of-care therapies in earlier lines of treatment for patients with newly diagnosed multiple myeloma.”
New data from the Phase 3 IsKia clinical trial, in partnership with the European Myeloma Network (EMN), evaluating the investigational combination of Sarclisa® (isatuximab-irfc) added to the standard-of-care regimen carfilzomib, lenalidomide and dexamethasone (KRd) in newly-diagnosed multiple myeloma (NDMM) are being presented. IsKia has the potential to provide insights in an area of unmet need in NDMM patients.
Presentations of the Sanofi oncology pipeline at ASH include updated efficacy and safety results from an open-label, first-in-human, dose-escalation study of an investigational CD123 targeting Natural Killer Cell Engager (NKCE). Results investigating SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia and high-risk myelodysplasia show data across all dose levels tested. Observed clinical remissions will also be presented.
Paul Rowe
Head of Medical Affairs, Specialty Care North America
“Our research highlights advances for our innovative treatments in hematology and our ambition in immunology. We are excited to share findings from our robust pipeline and investigational assets, including new data for our CD123 targeting natural killer cell engager in several hematological malignancies, and our BTK inhibitor in immune thrombocytopenia with a new mechanism of action for this condition. We are committed to pursuing scientific innovation and for difficult-to-treat hematologic diseases to transform care and improve outcomes.”
In hemophilia, our focus is to evolve treatment expectations for patients. Data from the Phase 3 XTEND-Kids trial evaluating factor activity levels in children younger than 12 years of age receiving once-weekly ALTUVIIIO® [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] will be presented. Additional qualitative insights from this trial based on the caregiver perspective will detail the potential impact of treatment with ALTUVIIIO for both children less than 12 years of age and their caregivers.
New results from Part B of the Phase 1/2 LUNA study for rilzabrutinib, a new and investigational Bruton’s tyrosine kinase (BTK) inhibition therapy for immune thrombocytopenia (ITP), will show encouraging data regarding the effect on platelet levels, safety profile, and quality of life measures in patients with relapsed ITP. ITP is a serious, acquired autoimmune blood disorder characterized by autoantibody-mediated platelet destruction and impaired platelet production, leading to thrombocytopenia and an increased risk of life-threatening bleeding episodes (like intracranial hemorrhage). Patients with ITP can experience quality-of-life impairments such as fatigue and cognitive impairment, and despite current treatment options, unmet needs remain for these patients. Rilzabrutinib is currently under clinical investigation and has not been evaluated by any regulatory authority.
An abstract evaluating the potential cost effectiveness of the U.S. Sanofi Promise Warranty Program for Cablivi® (caplacizumab-yhdp) will be shared. Cablivi is the first and only treatment for adults with acquired thrombotic thrombocytopenia purpura (aTTP) in combination with plasma exchange and immunosuppression.
A combined safety analysis from the two Phase 3 studies, CARDINAL and CADENZA, of Enjaymo® (sutimilab-jome) in adults with CAD will be presented. CAD is a rare autoimmune hemolytic anemia, with over 90% of patients suffering from uncontrolled complement-mediated hemolysis where part of the body’s immune system mistakenly destroys healthy red blood cells. Enjaymo is the first approved treatment for people with CAD in the U.S., EU, Switzerland, South Korea and Japan.
A full list of abstracts and presentations across the portfolios is included below.
Multiple Myeloma
- Abstract #1980: The Impact of Isatuximab Regimens on Hypogammaglobulinemia Occurrence, Recovery, and Associated Infections in Patients with Relapsed/Refractory Multiple Myeloma
- Saturday, December 9, 2023, Poster presentation: 5:30-7:30pm PT
- Abstract #4: Results of the Phase III Randomized IsKia Trial: Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone Vs Carfilzomib-Lenalidomide-Dexamethasone as Pre-Transplant Induction and Post-Transplant Consolidation in Newly Diagnosed Multiple Myeloma Patients
- Sunday, December 10, 2023, Oral presentation: 2-4pm PT
- Abstract #3360: Blood-Based Mass Spectrometry MRD Tracking (M-INSIGHT) in Multiple Myeloma Patients from Clinical Trial NCT02513186
- Sunday, December 10, 2023, Poster presentation: 6-8pm PT
- Abstract #6717: 30-minute Infusion of Isatuximab in Newly Diagnosed Multiple Myeloma (NDMM) Patients: Results of a Phase 1b Study
- Online publication
- Abstract #6732: Updated Results from a Matching-adjusted Indirect Comparison of Efficacy Outcomes for Isatuximab plus Pomalidomide and Dexamethasone versus Daratumumab plus Pomalidomide and Dexamethasone for the treatment of Patients with Relapsed and Refractory Multiple Myeloma
- Online publication
- Abstract #6734: Updated Results from a Matching-adjusted Indirect Comparison of Efficacy Outcomes for Isatuximab Plus Carfilzomib and Dexamethasone Versus Daratumumab plus Lenalidomide and Dexamethasone for the Treatment of Patients with Relapsed Multiple Myeloma
- Online publication
- Abstract #7419: Isatuximab plus Pomalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM) in Real-Life Context in France: IMAGE Subgroup Analysis Based on Prior Lines of Therapy and Refractory Status in Anti-CD38-Naïve Population
- Online publication
Oncology Pipeline
- Abstract #1418: Dual-targeting CD33/CD123 NANOBODY® T cell engager targeting leukemia blasts and stem/progenitor cells in relapsed AML
- Saturday December 9, 2023, Poster presentation: 5:30-7:30pm PT
- Abstract #1921: A CD38/CD28xCD3 Trispecific T-Cell Engager (TCE) As a Potentially Active Agent in Multiple Myeloma Patients Relapsed and/or Refractory (RRMM) to Anti-CD38 Monoclonal Antibodies (mAbs)
- Saturday December 9, 2023, Poster presentation: 5:30-7:30pm PT
- Abstract #3474: First-in-Human Study of the CD123 NK Cell Engager SAR443579 in Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia or High Risk-Myelodysplasia: Updated Safety, Efficacy, Pharmacokinetics and Pharmacodynamics
- Sunday, December 10, 2023, Poster presentation: 6-8pm PT
- Abstract #3629: Significant Cytokine Release Syndrome Risk Model with T-cell Engaging Therapies
- Sunday, December 10, 2023, Poster presentation: 6-8pm PT
- Abstract #4178: A CD38/CD28xCD3 Trispecific T-Cell Engager (TCE) As a Potentially Active Agent for the Treatment of Older Patients with Acute Myeloid Leukemia (AML)
- Monday, December 11, 2023, Poster presentation: 6-8pm PT
- Abstract #4384: The CD38/CD3xCD28 Trispecific Antibody (SAR442257) Potentially Represents a Novel Therapeutic Strategy for Peripheral T-cell Lymphomas
- Monday, December 11, 2023, Poster presentation: 6-8pm PT
- Abstract #4921: A Phase 2, Single-Arm, Multicohort, Open Label, Multicenter Trial of Off-the-Shelf Natural Killer Cells (SAR445419) in Patients with High-Risk Myeloid Malignancies Undergoing Allogeneic HSCT
- Monday, December 11, 2023, Poster presentation: 6-8pm PT
- Abstract #5972: A Phase I, Single-Arm, Open Label, Dose Escalation, Multicenter Study of Off-The-Shelf Natural Killer (NK) Cells (SAR445419) in Patients with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
- Online publication
Hemophilia A
- Abstract #2380: Real-World Unmet Needs in Patients with Hemophilia A without Inhibitors in the US: Results from the PicnicHealth Database
- Saturday, December 9, 2023, Oral presentation: 5:30-7:30 pm PT
- Abstract #2360: Experience with Accelerometer Physical Activity Tracking in Adults and Adolescents with Hemophilia A: Tool Validation Using Results from XTEND-1 Efanesoctocog Alfa Phase 3 Trials
- Saturday, December 9, 2023, Poster presentation: 5:30-7:30 pm PT
- Abstract #506: Once-Weekly Efanesoctocog Alfa Prophylaxis Provided High Sustained Factor VIII Activity Levels, Independent of Blood Group, in Children <12 Years of Age with Severe Hemophilia A
- Sunday, December 10, 2023, Oral presentation: 12-1:30 pm PT
- Abstract #507: Experiences with Efanesoctocog Alfa: Exit Interviews with Caregivers of Previously Treated Patients with Hemophilia A from the XTEND-Kids Phase 3 Clinical Trial
- Sunday, December 10, 2023, Oral presentation: 12-1:30 pm PT
- Abstract #3993: Treatment of Bleeding Episodes With Efanesoctocog Alfa in Children With Severe Hemophilia A in the XTEND-Kids Phase 3 Study
- Monday, December 11, 2023, Poster presentation: 6-8 pm PT
Hemophilia A and B
- Abstract #2614: Fitusiran Population Pharmacokinetic and Pharmacodynamic Modeling Utilizing Phase 3 Clinical Trial Data to Confirm Doses Tested in Phase 3 Trials to Support an Antithrombin-Based Dose Regimen
- Sunday, December 10, 2023, Poster presentation: 6-8 pm PT
Immune Thrombocytopenia
- Abstract #2379: Patient Experience with Signs, Symptoms, and Daily Impacts of Immune Thrombocytopenia
- Saturday, December 9, 2023, Poster presentation: 5:30-7:30 pm PT
- Abstract #391: First-time Users of Advanced Therapies Among Adult Patients with Persistent or Chronic Primary Immune Thrombocytopenia: Patient Characteristics, Treatment Switching Patterns, and Clinical Outcomes
- Sunday, December 10, 2023, Oral presentation: 9:30–11:30 am PT
- Abstract #685: Initial Report of Part B Phase 1/2 Efficacy and Safety Results for Bruton Tyrosine Kinase Inhibitor Rilzabrutinib in Patients With Relapsed Immune Thrombocytopenia
- Monday, December 11, 2023, Oral presentation: 10:30-12 pm PT,
- Abstract #690: The Effects of Rilzabrutinib, an Oral Bruton Tyrosine Kinase Inhibitor, on Bleeding Symptoms and Health-Related Quality of Life in Patients With Immune Thrombocytopenia
- Monday, December 11, 2023, Oral presentation: 10:30-12 pm PT
- Abstract #3953: Clinical and Economic Burden of Illness in Patients with Persistent or Chronic Primary Immune Thrombocytopenia Treated with TPO-RAs and Rituximab
- Monday, December 11, 2023, Poster presentation: 6-8 pm PT
Acquired Thrombotic Thrombocytopenic Purpura
- Abstract #5056: Cost-Effectiveness of Caplacizumab in the Warranty Program in Immune Thrombotic Thrombocytopenic Purpura in the USA
- Monday, December 11, 2023, Poster presentation: 6-8 pm PT
Cold Agglutinin Disease
- Abstract #1069: Classical Complement Inhibition by SAR445088 (BIVV020) in Adults with Cold Agglutinin Disease: Safety, Tolerability and Activity Results From the Open-Label, Non-Randomized, Single-Dose Phase 1b Study
- Saturday, December 9, 2023, Poster presentation: 5:30-7:30 pm PT
- Abstract #3833: Combined Safety Data for Sutimlimab in Cold Agglutinin Disease: A Post-Hoc Analysis of the Phase 3 CARDINAL and CADENZA Studies
- Monday, December 11, 2023, Poster presentation: 6-8 pm PT
- Abstract #3835: A U.S. Retrospective Observational Study of Rituximab Use in Cold Agglutinin Disease
- Monday, December 11, 2023, Poster Presentation: 6-8 pm PT
About Sarclisa
Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.
Based on the Phase 3 ICARIA-MM study, Sarclisa is approved in 52 countries, including the U.S. and EU, in combination with pomalidomide and dexamethasone for the treatment of certain patients with relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor. Based on the Phase 3 IKEMA study, Sarclisa is also approved in multiple countries in combination with carfilzomib and dexamethasone, including in the U.S. for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA).
Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies, and its safety and efficacy have not been evaluated by any regulatory authority outside of its approved indication.
For more information on Sarclisa clinical trials, please visit www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS
What is SARCLISA?
SARCLISA is a prescription medicine used in combination with:
- The medicines pomalidomide and dexamethasone, to treat adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor to treat multiple myeloma.
- The medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment and they did not work or are no longer working.
It is not known if SARCLISA is safe and effective in children.
Important Safety Information
Do not receive SARCLISA if you have a history of a severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in the full Prescribing Information).
Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:
- Have heart problems, if your healthcare provider prescribes SARCLISA in combination with carfilzomib and dexamethasone for you.
- Have had shingles (herpes zoster)
- Are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive SARCLISA during pregnancy.
- Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA.
- Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time.
- Are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not breastfeed during treatment with SARCLISA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive SARCLISA?
- SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
- SARCLISA is given in treatment cycles of 28 days (4 weeks), together with either the medicines pomalidomide and dexamethasone, or carfilzomib and dexamethasone.
- In cycle 1, SARCLISA is usually given weekly.
- Starting in cycle 2, SARCLISA is usually given every 2 weeks.
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
- Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe).
What are the possible side effects of SARCLISA?
SARCLISA may cause serious side effects, including:
- Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe or life threatening.
- Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each dose of SARCLISA.
- Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA if you have an infusion reaction.
Get medical help right away if you develop any of the following symptoms of infusion reaction during or after an infusion of SARCLISA:
— shortness of breath, wheezing, or trouble breathing
— swelling of the face, mouth, throat, or tongue
— throat tightness
— palpitations
— dizziness, lightheadedness, or fainting
— headache
— cough
— rash or itching
— nausea
— runny or stuffy nose
— chills
- Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. You may have an increased risk of getting certain infections, such as upper and lower respiratory tract infections and urinary tract infections.
Your healthcare provider will check your blood cell counts during treatment with SARCLISA. Your healthcare provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA.
Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA.
- Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA.
- Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA. Tell all of your healthcare providers that you are being treated with SARCLISA before receiving blood transfusions.
The most common side effects of SARCLISA in combination with pomalidomide and dexamethasone include:
- upper respiratory tract infection
- lung infection (pneumonia)
- diarrhea
- decreased red blood cell count (anemia)
- decreased platelet count (thrombocytopenia)
The most common side effects of SARCLISA in combination with carfilzomib and dexamethasone include:
- upper respiratory tract infection
- tiredness and weakness
- high blood pressure
- diarrhea
- lung infection (pneumonia)
- trouble breathing
- trouble sleeping
- bronchitis
- cough
- back pain
- decreased red blood cell count (anemia)
- decreased platelet count (thrombocytopenia)
Heart failure can happen during treatment with SARCLISA in combination with carfilzomib and dexamethasone. Tell your healthcare provider right away if you develop any of the following symptoms:
- trouble breathing
- cough
- swelling of your ankles, feet, or legs
These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information.
About ALTUVIIIO®
ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] is a first-in-class high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. In adults and adolescents, ALTUVIIIO has a 3 to 4-fold longer half-life relative to standard and extended half-life factor VIII products. Once-weekly treatment with ALTUVIIIO provides high-sustained factor activity levels within the normal to near-normal range for most of the week in adults and for approximately three days in children. ALTUVIIIO is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on other factor VIII therapies. ALTUVIIIO builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation.
Sobi and Sanofi collaborate on the development and commercialization of efanesoctocog alfa, or ALTUVIIIO in the US.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS
INDICATION
ALTUVIIIO® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is an injectable medicine that is used to control and reduce the number of bleeding episodes in people with hemophilia A (congenital Factor VIII deficiency).
Your healthcare provider may give you ALTUVIIIO when you have surgery.
IMPORTANT SAFETY INFORMATION
What is the most important information I need to know about ALTUVIIIO?
Do not attempt to give yourself an injection unless you have been taught how by your healthcare provider or hemophilia center. You must carefully follow your healthcare provider's instructions regarding the dose and schedule for injecting ALTUVIIIO so that your treatment will work best for you.
Who should not use ALTUVIIIO?
You should not use ALTUVIIIO if you have had an allergic reaction to it in the past.
What should I tell my healthcare provider before using ALTUVIIIO?
Tell your healthcare provider if you have had any medical problems, take any medications, including prescription and non-prescription medicines, supplements, or herbal medicines, are breastfeeding, or are pregnant or planning to become pregnant.
What are the possible side effects of ALTUVIIIO?
You can have an allergic reaction to ALTUVIIIO. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.
Your body can also make antibodies called “inhibitors” against ALTUVIIIO. This can stop ALTUVIIIO from working properly. Your healthcare provider may give you blood tests to check for inhibitors.
The common side effects of ALTUVIIIO are headache, joint pain, and back pain.
These are not the only possible side effects of ALTUVIIIO. Tell your healthcare provider about any side effect that bothers you or does not go away.
Please see full Prescribing Information.
About the Sanofi and Sobi collaboration
Sobi and Sanofi collaborate on the development and commercialization of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialization of efanesoctocog alfa, or ALTUVIIIO in the US. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory.
About fitusiran
Fitusiran is an investigational, subcutaneously administered small interference RNA therapeutic in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors. Fitusiran is designed to lower antithrombin, a protein that inhibits blood clotting, with the goal of promoting thrombin generation to rebalance hemostasis and prevent bleeds. Fitusiran utilizes Alnylam Pharmaceutical Inc.’s ESC-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency and durability.
Fitusiran is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.
About rilzabrutinib
Rilzabrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor incorporating Sanofi’s TAILORED COVALENCY® technology being investigated for the treatment of immune-mediated diseases, including immune thrombocytopenia (ITP). BTK is an intracellular signaling molecule involved in innate and adaptive immune responses related to certain immune-mediated diseases. By inhibiting BTK, rilzabrutinib has the potential to target the underlying disease pathogenesis.
Rilzabrutinib is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.
About Enjaymo® (sutimlimab-jome)
Enjaymo is currently the only approved treatment for hemolysis in adults with CAD. It is a first-in-class humanized monoclonal antibody that is designed to selectively target and inhibit the classical complement pathway specific serine protease, C1s. By blocking C1s of the classical complement pathway, Enjaymo inhibits C1-activated hemolysis in CAD to prevent hemolysis, while leaving the lectin and alternative pathways intact.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS
INDICATION
ENJAYMO is a prescription medicine used to decrease the need for red blood cell transfusion due to the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD). It is not known if ENJAYMO is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not receive ENJAYMO if you are allergic to sutimlimab-jome or any of the ingredients in ENJAYMO.
ENJAYMO can cause serious side effects, including:
- Serious Infections: ENJAYMO is a prescription medicine that affects your immune system. ENJAYMO can lower the ability of your immune system to fight infections. People who take ENJAYMO may have an increased risk of getting infections caused by certain kinds of bacteria such as Neisseria meningitides, Streptococcus pneumoniae, and Haemophilus influenzae. These infections may be serious or life-threatening. Some infections may quickly become life- threatening or cause death if not recognized and treated early.
- You need to receive vaccinations against infections caused by certain kinds of bacteria at least 2 weeks before your first dose of ENJAYMO. You may need to have additional vaccinations during treatment
- If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should receive vaccinations as soon as possible.
- Vaccinations may reduce the risk of these infections, but do not prevent all infections. Call your healthcare provider or get medical help right away if you get any new signs and symptoms of an infection, including:
- fever
- severe headache with stiff neck or back
- pain during urination or urinating more often than usual
- cough or difficulty breathing
- flu-like symptoms
- pain, redness or swelling of the skin
- Infusion-related reactions: Treatment with ENJAYMO may cause infusion-related reactions, including allergic reactions that may be serious or life-threatening. Your healthcare provider may slow down or stop your ENJAYMO infusion if you have an infusion-related reaction, and will treat your symptoms if needed. Tell your healthcare provider right away if you develop symptoms during your ENJAYMO infusion that may mean you are having an infusion-related reaction, including:
- shortness of breath
- decrease in blood pressure
- chest discomfort
- rapid heartbeat
- nausea
- injection site reaction
- flushing
- headache
- dizziness
- rash
- itchy skin
- Risk of autoimmune disease: ENJAYMO may increase your risk for developing an autoimmune disease such as systemic lupus erythematosus (SLE). Tell your healthcare provider and get medical help if you develop any symptoms of SLE, including:
- joint pain or swelling
- rash on the cheeks and nose
- unexplained fever
- If you have CAD and you stop receiving ENJAYMO, your healthcare provider should monitor you closely for return of your symptoms after you stop ENJAYMO. Stopping ENJAYMO may cause the breakdown of your red blood cells due to CAD to return. Symptoms or problems that can happen due to red blood cell breakdown include:
- tiredness
- shortness of breath
- rapid heart rate
- blood in your urine or dark urine
The most common side effects of ENJAYMO include:
- increase in blood pressure
- urinary tract infection
- respiratory tract infection
- bacterial infection
- swelling in lower legs or hands
- joint pain
- headache
- nausea
- runny nose
- bluish color to the lips and skin
- dizziness
- feeling tired or weak
- cough
- changes in color or sensation in the fingers and toes (Raynaud's phenomenon)
These are not all the possible side effects of ENJAYMO. Call your doctor for medical advice about side effects.
Before receiving ENJAYMO, tell your healthcare provider about all of your medical conditions, including if you:
- have a fever or infection, including a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- have an autoimmune disease such as systemic lupus erythematosus (SLE), also known as lupus.
- are pregnant or plan to become pregnant. It is not known if ENJAYMO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ENJAYMO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.
Please see accompanying full Prescribing Information.
About Cablivi® (caplacizumab-yhdp)
Cablivi is a von Willebrand Factor (vWF) antibody fragment, which inhibits the interaction between ultra-large vWF multimers and platelets and, therefore, stops the formation of the micro-clots that can form during an acute episode of acquired thrombotic thrombocytopenia purpura. Cablivi was approved in the European Union in August 2018 and in the United States in February 2019.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS
What is CABLIVI?
CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Who should not take CABLIVI?
Do not take CABLIVI if you’ve had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI.
What should I tell my healthcare team before starting CABLIVI?
Tell your doctor if you have a medical condition including if you have a bleeding disorder. Tell your doctor about any medicines you take, including medicines that increase your risk of bleeding such as anti-coagulants and anti-platelet agents.
Talk to your doctor before scheduling any surgery, medical or dental procedure.
What are the possible side effects of CABLIVI?
CABLIVI can cause severe bleeding. In clinical studies, severe bleeding adverse reactions of nosebleed, bleeding from the gums, bleeding in the stomach or intestines, and bleeding from the uterus were each reported in 1% of subjects. In the post-marketing setting, cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI. Contact your doctor immediately if symptoms of excessive bruising, excessive bleeding, or major bleeding occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness.
You may have a higher risk of bleeding if you have a bleeding disorder (i.e. hemophilia) or if you take other medicines that increase your risk of bleeding such as anti-coagulants and anti-platelet agents. CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.
The most common side effects include nosebleed, headache and bleeding gums.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.
Please see accompanying full Prescribing Information.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com
Investor Relations
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.