Sanofi Genzyme and Regeneron Announce FDA Approval of First Targeted Biologic Therapy for Eczema

Sanofi and Regeneron Pharmaceuticals announced that the FDA has approved Dupixent, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD), a form of eczema, whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids.

AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.

Dupixent was evaluated by the FDA with Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions. This followed the FDA’s 2014 Breakthrough Therapy designation for Dupixent for inadequately controlled moderate-to-severe AD. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs developed for serious or life-threatening conditions. Dupixent represents the first time this designation was granted for a dermatological disease, other than in dermatologic cancers.

Sanofi Genzyme and Regeneron will market Dupixent in the United States. The Wholesale Acquisition Cost (WAC) of Dupixent in the United States is $37,000 annually. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts, rebates or patient assistance programs. (Source: Sanofi Genzyme Website, 28 March, 2017)

View the Multimedia News Release: http://www.multivu.com/players/English/7951851-dupixent-regeneron-sanofi-fda-approval/