Sanofi US News

The FDA decision date for avalglucosidase alfa, an investigational enzyme replacement therapy, is set for May 18, 2021

Complete Response Letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility

Oncology: Results from an interim analysis of Sarclisa® (isatuximab-irfc) in patients with relapsed multiple myeloma, including an evaluation of depth of response, will be shared in an oral presentation

- Completed rolling submission of the Biologics License Application (BLA) for teplizumab in the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals -

* Award recognizes innovative accomplishments in facility design, construction, and operation that are setting the standard for pharmaceutical facilities of the future

- Submission of chemistry, manufacturing and controls (CMC) and administrative information modules represent completion of the Company's BLA submission for teplizumab -

Results of two clinical studies in adults and children with acid sphingomyelinase deficiency (ASMD) presented at the American Society of Human Genetics 2020 Virtual Meeting

- First Phase 3 trial in eosinophilic esophagitis (EoE) to show a biologic medicine significantly improved structural and histologic measures, while rapidly improving ability to swallow in patients 12 years and older

* $1 million in research funding to support PD GENEration, a first-of-its-kind national study offering free genetic testing and counseling for people with Parkinson's disease (PD)

Data in children aged 6-11 further suggest Dupixent has potential to be best-in-class treatment option

- Healthcare professional and patient campaigns focus on screening for early-stage T1D-

- Expect to complete filing of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 -

In the overall trial population, Libtayo reduced risk of death by 32% compared to chemotherapy

Libtayo is the first investigational medicine to show a clinical benefit in advanced basal cell carcinoma following treatment with a hedgehog inhibitor in a prospective trial

* Designation based on positive results from Part A of pivotal Phase 3 trial

BIVV001 is the first investigational factor VIII therapy independent of von Willebrand Factor and has the potential to transform replacement therapy for people with hemophilia A

- New data on investigational brain-penetrant BTK inhibitor tolebrutinib (SAR442168) further support its potential in modulating disabling inflammatory processes within the central nervous system

- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

Potential to be the first approved therapeutic for the treatment of Non-responsive Celiac Disease

* Further strengthens core R&D areas of autoimmune and allergic diseases

-Former Director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, brings extensive regulatory expertise and experience to Provention-

- Completed commercial-scale drug substance PPQ campaign ahead of schedule, enabling the expected on-time completion of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 -

- Promising vaccine candidate selected by U.S. government’s Operation Warp Speed

- Nirsevimab reduced respiratory syncytial virus (RSV) lower respiratory tract infections by 70 percent and related hospitalizations by 78 percent1

* New alliance will use insights from translational and clinical studies to better identify targets, combinations and potential new indications for current medicines

* Single-dose (300 mg) pre-filled pen provides additional administration option to adults and adolescents who are prescribed Dupixent

-One Course of Teplizumab Now Shown to Delay Insulin-Dependent T1D by a Median of Approximately Three Years Compared to Placebo-

- Preclinical data show anti-tumor activity in Sanofi's investigational compounds, including an oral selective estrogen receptor degrader (SERD) and an anti-CEACAM5 antibody-drug conjugate

* Additional donation of factor therapy fulfills 2014 pledge to donate up to an unprecedented 1 billion IUs for humanitarian use

Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination) reduced risk of disease progression or death by 47% versus standard of care carfilzomib and dexamethasone (Kd) alone

Across all groups combined, complete responses (CR) are now 16%; in the metastatic group with the longest follow-up, CRs are 20% representing a 200% increase over two years

- In the pivotal trial, more than twice as many children achieved clear or almost clear skin and more than four times achieved itch reduction with Dupixent plus topical corticosteroids (TCS) compared to TCS alone

- Nancy Wysenski, a Seasoned Pharmaceutical Executive with Rare Disease and Commercialization Experience, Appointed as a New Director -

-- The preclinical prototype vaccine is well-tolerated and provides strong protection against coxsackievirus B infections and diabetes in relevant animal models

Sutimlimab targets C1-activated hemolysis in cold agglutinin disease (CAD)