Sanofi and Regeneron Receive Positive CHMP Opinion for Dupixent® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis

Sanofi and Regeneron Receive Positive CHMP Opinion for Dupixent^® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis

- First investigational targeted biologic in the European Union to
receive positive CHMP opinion for atopic dermatitis -

Paris, France and Tarrytown, N.Y. - July 21, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Dupixent^® (dupilumab), recommending its approval in Europe for use in adults with moderate-to-severe atopic dermatitis  who are candidates for systemic therapy.

Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.^{[1],[2],[3],[4]} Moderate-to-severe atopic dermatitis is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.^[5] Itch is one of the most burdensome symptoms for patients and can be debilitating. In addition, people with moderate-to-severe atopic dermatitis experience a high level of disrupted sleep, and increased anxiety and depression symptoms due to their disease.^[6]

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 atopic dermatitis. ^[7]  If approved, Dupixent 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.⁷ Dupixent can be used with or without topical corticosteroids.

The European Commission (EC) is expected to adopt a final decision on the Marketing Authorization Application (MAA) for Dupixent in the European Union in the coming months. The CHMP opinion is based on studies from the global LIBERTY atopic dermatitis clinical trial program, including SOLO 1, SOLO 2, SOLO-CONTINUE,CHRONOS and CAFÉ.^7,[8],[9] These studies incorporated data from nearly 3,000 adult patients with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or immunosuppressant such as cyclosporine, or when those therapies were not advisable.