EMA committee backs approval of Sanofi, Regeneron's Dupixent for atopic dermatitis

Sanofi and Regeneron Pharmaceuticals announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding approval of Dupixent (dupilumab) for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. The drugmakers noted that the drug, which inhibits IL-4 and IL-13, is the first investigational targeted biologic in the EU to receive a positive CHMP opinion for atopic dermatitis.

According to Sanofi and Regeneron, the CHMP's opinion was based on studies from the global LIBERTY atopic dermatitis clinical trial programme consisting of data for about 3000 adults with moderate-to-severe atopic dermatitis that was inadequately controlled by topical prescription therapies or immunosuppressants such as cyclosporine, or when those therapies were not suitable. In the LIBERTY AD SOLO 1 and SOLO 2 trials unveiled in April 2016, Dupixent was associated with improvements of several measures, including overall disease severity, skin clearing, itching, quality of life and mental health, versus placebo. Additionally, in the LIBERTY AD CHRONOS trial, the addition of the drug to topical corticosteroids produced clear or nearly complete skin in 39 percent of patients, versus 12 percent for topical corticosteroids alone.

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Dupixent was previously authorised (https://www.firstwordpharma.com/node/1459456) in this indication by the FDA in March. For related analysis, see ViewPoints: Regeneron happy to hang its hat on Dupixent's hot start, and ViewPoints: ICER endorses Regeneron, Sanofi's pricing of Dupixent – will it carry weight with payers?

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