Treatment for atopic dermatitis receives positive CHMP opinion

Sanofi and Regeneron Pharmaceuticals have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for marketing authorization of Dupixent (dupilumab).

Dupixent, a human monoclonal antibody, has been recommended for use within Europe of adult patients suffering with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. It has been specifically designed to inhibit overactive signaling of two key proteins that are believed to be major factors in the underlying inflammation of the condition.

It is anticipated that the European Commission (EC) will issue a final decision on the marketing authorisation application (MAA) for Dupixent in the European Union over the next few months. The CHMP opinion has been based on studies from the global LIBERTY atopic dermatitis clinical trial programme, which 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.

If approved, the therapy will be available in a pre-filled syringe for self-administration by a patient as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids.

Sanofi is a global healthcare leader that discovers, develops and distributes therapeutic solutions.

Regeneron is a biotechnology company that invents medicines for people with serious diseases.