The European Medicines Agency (EMA) has recently accepted to review the Marketing Authorization Application (MAA) of Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA (ADR) (NYSE:SNY) for Dupixent (dupilumab) as a treatment for adult moderate-to-severe atopic dermatitis (AD) patients who are systemic therapy candidates.
Dupixent is an investigational biologic therapy that inhibits the signaling of two key cytokines necessary for the type 2 immune response, IL-4 and IL-13.
Regeneron Pharmaceuticals and Sanofi had included in their MAA supporting data from three Phase 3 clinical trials under the LIBERTY AD clinical development program, which involves over 2,500 patients.
The clinical trials had evaluated Dupixent as a monotherapy (SOLO 1 and SOLO 2), and in accompanying administration with topical corticosteroids (CHRONOS) among adult moderate-to-severe AD patients whose conditions are not controlled with topical prescriptions adequately.
Biologics License Application (BLA)
The US Food and Drug Administration (FDA), on the other hand, had granted Priority Review to the companies’ BLA for Dupixent as a treatment for adult patients with moderate-to-severe AD in September. As per the Prescription Drug User Fee Act (PDUFA), the target action date for the BLA is March 29.
Dupixent
The safety and efficacy of Dupixent for any indication has not yet been completely assessed by any regulatory commission. Aside from moderate-to-severe AD, Dupixent is also currently being evaluated for the potential treatment of asthma, eosinophilic esophagitis, nasal polyposis, and pediatric AD.
Once approved by the EMA and the US FDA, it will be marketed by Regeneron and Sanofi Genzyme.
Regeneron Pharmaceuticals’ Ernst & Young (EY) Entrepreneurs of the Year
In other news, Leonard Schleifer, M.D., Ph.D, Regeneron Pharmaceuticals CEO, President, and Founder, and George Yancopoulos, M.D., Ph.D, Regeneron Pharmaceuticals Chief Scientific Officer (CSO), Founding Scientist, and President of Regeneron Laboratories, have been recognized recently as the EY Entrepreneurs of the Year 2016 National Award Winners in the Life Sciences category.
Roy Vagelos, M.D., Regeneron Pharmaceuticals Board of Directors Chairman, has commended the combined leadership prowess of Schleifer and Yancopoulos.
“This spirit has enabled the Regeneron team to bring important medicines to people in need and to advance a promising pipeline of therapies for serious diseases,” he noted.
On Thursday, Regeneron Pharmaceuticals has closed at $369.15 while Sanofi has closed at $39.77.