Sanofi-Regeneron Dupixent gets FDA priority review as add-on therapy for kids with eczema
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The U.S. Food and Drug Administration granted priority review to Regeneron Pharmaceutical (NASDAQ:REGN) and Sanofi (NASDAQ:SNY)'s application seeking approval of Dupixent (dupilumab) as an add-on maintenance therapy for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical drugs or when those therapies are not advisable.

The FDA is expected to make a decision by June 9.
The companies said that, if approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children.
Atopic dermatitis, also known as eczema, is a condition that makes the skin red and itchy.
The company's supplemental biologics license application is backed by data from a phase 3 trial which showed that Dupixent added to standard-of-care topical corticosteroids (TCS) improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone.
SNY -0.54% pre-market to $53.36.