Sanofi US News

- Potential to be the first vaccine for the prevention of coxsackievirus B, a presumed infectious trigger in the development of type 1 diabetes and celiac disease -

Phase 3 trial initiated to evaluate rilzabrutinib, the potential first BTK inhibitor (Bruton’s tyrosine kinase inhibitor) for the treatment of immune thrombocytopenia

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