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EMA accepts marketing authorization application for Dupixent for atopic dermatitis

Regeneron Pharmaceuticals and Sanofi have announced in a press release that the European Medicines Agency has accepted to review the marketing authorization application for Dupixent for treating adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

Dupixent (dubilumab) inhibits signaling of the cytokines IL-4 and IL-13, according to the release. The marketing authorization application was based on three phase 3 trials of 2,500 patients.

The studies evaluated dupilumab as monotherapy and in concomitant administration with topical corticosteroids in adults with moderate-to-severe atopic dermatitis whose disease has not been adequately controlled with topical prescription therapies.

The FDA accepted a biologics license application for priority review for Dupixent in September 2016, with a target action date of March 29, 2017, according to the release.

Reference: www.regeneron.com