Posted by Michael Wonder on 22 Jul 2017
Sanofi and Regeneron receive positive CHMP opinion for Dupixent (dupilumab) to treat adult patients with moderate-to-severe atopic dermatitis
21 July 2017 - First investigational targeted biologic in the European Union to receive positive CHMP opinion for atopic dermatitis.
Sanofi and Regeneron Pharmaceuticals today announced that the European Medicine Agency’s CHMP has adopted a positive opinion for the marketing authorisation of Dupixent (dupilumab), recommending its approval in Europe for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
The European Commission 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.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.
