Dupixent receives European positive opinion for treating adults with atopic dermatitis

Regeneron Pharmaceuticals and Sanofi announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has given a positive opinion for the marketing authorization of Dupixent in Europe for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

Dupixent (dupilumab), a human monoclonal antibody, is designed to inhibit overactive signaling of two key proteins, interleukin-4 (IL-4) and IL-13. Dupilumab will come in

a pre-filled syringe for self-administration by a patient as a subcutaneous injection every other week after an initial loading dose if it is approved, and can be used with or without topical corticosteroids, according to a news release.

The European Commission is expected to make a final decision on the marketing authorization application for Dupixent in the European Union in the coming months.

The positive opinion was based on studies that incorporated data from nearly 3,000 adults with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical prescription therapies or immunosuppressants such as cyclosporine, or when those therapies were not advisable, according to the release.

Dupixent is approved in the United States for the treatment of adults with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Serious adverse events reported with dupilumab include allergic reactions, including fever, ill feeling, swollen lymph nodes, hives, itching, joint pain or skin rash, and eye problems, including eye pain or changes in vision, according to the release.

Common adverse events reported include site reactions, eye and eyelid inflammation and cold sores on the mouth or lips.

Reference: www.regeneron.com; www.sanofi.com