Sanofi US News

• Clinical trials will be conducted at Centers of Excellence at four historically Black medical schools
• The Beacon of Hope program aims to strengthen clinical trial capabilities, improve the quality and inclusivity of clinical trials and help rebuild trust in the healthcare system within Black communities
• Initiative is part of Sanofi's broader commitment to increase clinical trial diversity throughout the entire ecosystem – from study design and eligibility criteria to site selection, recruitment materials, and engagement with local communities

First and only investigational Phase 3 trial to show positive results in these young children; results follow recent approval of Dupixent in people with eosinophilic esophagitis aged 12 years and older who weigh at least 40 kilograms

- A median annualized bleeding rate (ABR) of 0.0 was reported in the overall study population during fitusiran prophylaxis (80 mg monthly)

- Investigational once-weekly efanesoctocog alfa prophylaxis met the primary efficacy endpoint providing clinically meaningful bleed protection for people with severe hemophilia A

Through the Insulins Valyou Savings Program, uninsured people living with diabetes will pay fixed $35 for a 30-day supply of Sanofi insulins

Results of nationally representative survey come as the ACIP evaluates data to provide guidance for flu vaccines in this vulnerable population

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood

Sanofi will receive an upfront payment of $900 million, and an 11% royalty on worldwide net sales of Libtayo

Efanesoctocog alfa is the first factor VIII therapy to be awarded Breakthrough Therapy designation by the FDA

Data to be shared across multiple tumor types, including multiple myeloma, lung cancer and breast cancer

Latest results of the Phase 3 IKEMA trial demonstrate the longest median progression free survival (mPFS) on a proteasome inhibitor backbone in patients who relapsed after a prior therapy, including lenalidomide

*Results demonstrate strong, but not universal, correlation between organ clinical responses and clinically meaningful improvements in patient-reported outcomes from a pooled analysis of ROCKstar and KD025-208 clinical trials

Results published today in the New England Journal of Medicine showed that treatment with rilzabrutinib resulted in a rapid and durable increase in platelet count in patients with heavily pretreated immune thrombocytopenia (ITP)

If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis

Dupixent significantly reduced itch at 12 weeks, and at 24 weeks nearly three times as many Dupixent patients experienced clinically meaningful reductions in itch and skin lesions

Once-weekly efanesoctocog alfa met primary endpoint in phase 3 study, resulting in a clinically meaningful prevention of bleeding episodes (bleed protection)

Dupixent 300 mg weekly is the only biologic medicine to show positive, clinically meaningful Phase 3 results in adults and adolescents with eosinophilic esophagitis

In this Phase 3 trial, Dupixent added to standard-of-care antihistamines nearly doubled reduction in itch and urticaria activity scores compared to standard-of-care alone at 24 weeks in biologic-naïve patients uncontrolled on antihistamines

Preclinical findings showed that tolebrutinib, among the investigational BTK inhibitors tested, had the best combination of brain penetration and potency that reinforces its potential to impact neuroinflammation

-Company resubmits Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals to the U.S. Food and Drug Administration (FDA)-

If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children

Enjaymo is the only approved treatment to decrease the need for red blood cell transfusion due to hemolysis, the destruction of red blood cells, in adults with cold agglutinin disease (CAD)

Late-breaking pivotal data show significant disease improvements in eosinophilic esophagitis and also in chronic spontaneous urticaria

- Company to Host Conference Call Tomorrow, January 28th at 8:00 AM ET -

- PRV-3279 is Designed to Intercept B-Cell Mediated Autoimmune Diseases -

Dupixent is the first and only medicine to demonstrate positive Phase 3 results in prurigo nodularis, confirming the potential benefit of targeting IL-4 and IL-13, central drivers of type 2 inflammation, to address itch and skin lesions

Dupixent significantly improved skin clearance and reduced overall disease severity and itch in a Pivotal trial that met all primary and secondary endpoints

Sarclisa combination therapy is first to demonstrate superiority to standard of care lenalidomide, bortezomib and dexamethasone (RVd) in a Phase 3 trial

Dupixent significantly reduced severe asthma attacks and improved lung function and asthma control in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma

* Regardless of gender or sexual orientation, employees welcoming a child into their family receive equal amount of paid time off

Andrew Drechsler to Retire as Chief Financial Officer in December

PRV-101 was well tolerated and elicited high titers of virus-neutralizing antibodies in a dose-dependent fashion in healthy volunteers

Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from first Phase 3 trial

Pivotal trial met primary and all key secondary endpoints

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option

First study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older

Presentations focused on respiratory syncytial virus, meningococcal disease, and influenza

*Phase 3 trial met its primary and key secondary endpoints

Data collection completed for PROTECT Pharmacokinetic/Pharmacodynamic (PK/PD) substudy

Dupixent rapidly improved symptoms after first dose, improving itch in one week and skin clearance in two weeks

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile

Libtayo combined with chemotherapy increased median overall survival from 13 to 22 months, leading to a 29% reduction in the risk of death

Fifth disease that Dupixent has demonstrated positive pivotal results

Designation is the first step in a new MHRA initiative to accelerate the development and access to innovative medicines in the UK post-Brexit

Previously reported pharmacokinetic (PK) drug product comparability considerations remain outstanding

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented

* Study also shows more people on Soliqua 100/33 had improved blood sugar control without weight gain and without low blood sugar events (hypoglycemia) in first head-to-head comparison with premixed insulin