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Regeneron & Sanofi's Atopic Dermatitis Drug Gets FDA Nod

Regeneron Pharmaceuticals, Inc. REGN and its partner Sanofi SNY announced that the FDA has approved the Dupixent (dupilumab) Injection, for the treatment of adults with moderate-to-severe atopic dermatitis (AD).

Per the companies, this is the first and only biologic medicine approved for the treatment of adults suffering from AD.

Regeneron’s share price shows that the company has underperformed the Zacks classified Medical - Biomedical and Genetics industry year to date. The stock gained 4.2% compared to the industry’s gain of 6.3%.

The approval of Dupixent was based on data from the global LIBERTY AD clinical program, which included three randomized phase III studies. In all these studies, Dupixent, alone, or with topical corticosteroids, met the primary and key secondary endpoints.

We note that Dupixent received the Breakthrough Therapy designation by the FDA in 2014, for the treatment of adults with moderate-to-severe AD, who are not...