Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

EMA Reviews Regeneron Pharmaceuticals Inc (REGN), Sanofi SA (ADR) (SNY) Dupixent MAA

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.

pharmacist, senior, man, talking, helpful, nhs, helping, counter, medication, older, american, drugs, woman, shelves, male, pack, usa, medical, practice, horizontal, adult,

Monkey Business Images/

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA (ADR) (NYSE:SNY) 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.


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.

Follow Regeneron Pharmaceuticals Inc. (NASDAQ:REGN)
Trade (NASDAQ:REGN) Now!

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 Inc (NASDAQ:REGN) has closed at $369.15 while Sanofi SA (ADR) (NYSE:SNY) has closed at $39.77.

Follow Sanofi Aventis (NYSE:SNY)
Trade (NYSE:SNY) Now!

Note: This article is written by Adam Russell and originally published at Market Exclusive.

DOWNLOAD FREE REPORT: Warren Buffett's Best Stock Picks

Let Warren Buffett, George Soros, Steve Cohen, and Daniel Loeb WORK FOR YOU.

If you want to beat the low cost index funds by 19 percentage points per year, look no further than our monthly newsletter.In this free report you can find an in-depth analysis of the performance of Warren Buffett's entire historical stock picks. We uncovered Warren Buffett's Best Stock Picks and a way to for Buffett to improve his returns by more than 4 percentage points per year.

Bonus Biotech Stock Pick: You can also find a detailed bonus biotech stock pick that we expect to return more than 50% within 12 months.
Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.