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Sanofi/Regeneron's Kevzara Gets Marketing Approval in EU

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SanofiSNY and partner Regeneron Pharmaceuticals, Inc. REGN announced that the European Commission has granted marketing approval to its rheumatoid arthritis (RA) drug Kevzara.

The IL-6R antibody has been approved for the treatment of adult patients in combination with methotrexate (MTX) with moderate-to-severely active RA, who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs) such as MTX.

So far this year, Sanofi's shares are up 22.8%, better than a 15% increase for the Zacks classified Large-Cap Pharma industry.

Kevzara was approved in the U.S. in May and in Canada in February this year for the same indication.

We remind investors that the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had granted a positive opinion recommending marketing approval of Kevzara in the EU in April this year.

The marketing approval in the EU was based on results from seven phase III trials in the global SARIL-RA clinical development program conducted in more than 3,300 adults with moderate-to-severely active RA who had an inadequate response to previous treatment regimens. Kevzara demonstrated statistically significant, clinically-meaningful improvements in combination with conventional DMARDs, including MTX in two pivotal phase III studies.

While Kevzara has blockbuster potential, the RA market is highly crowded given the presence of treatments like AbbVie, Inc.'s ABBV Humira and Pfizer, Inc.'s PFE Xeljanz among others. Moreover, the patient population is huge with many patients spending years on different treatments without achieving their treatment goals. With RA affecting about 2.9 million people in Europe, Kevzara represents a new treatment option for patients.

Sanofi currently has a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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