EC grants marketing authorisation for Sanofi and Regeneron’s Dupixent for AD

The European Commission (EC) has granted marketing authorisation for Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) to treat adults with moderate to severe atopic dermatitis (AD), a form of eczema.

Approved for AD patients who are candidates for systemic therapy, Dupixent is the first targeted biologic in the European Union to receive authorisation for the chronic inflammatory disease.

Dupixent is a human monoclonal antibody jointly developed by Regeneron and Sanofi under a global collaboration agreement. It is available in a pre-filled syringe and can be self-administered by a patient as a subcutaneous injection.

The drug is designed to specifically inhibit overactive signalling of two key proteins, IL-4 and IL-13, which are considered to be major drivers of the persistent underlying cause of AD and certain other allergic or atopic diseases.

Sanofi Global R&D president Elias Zerhouni said: "This approval of Dupixent in Europe demonstrates our approach of bringing innovative new therapies to those living with high unmet medical need and today’s approval represents an important milestone for people living with moderate to severe atopic dermatitis in Europe.

"Dupixent targets an underlying cause of atopic dermatitis, helps clear the skin, manage the persistent debilitating itch, and improve the overall quality of life.

"We are now focused on quickly making this important new treatment option available to people across Europe who live with this systemic disease."

The approval is based on studies from the global LIBERTY AD clinical trial programme, including SOLO 1, SOLO 2, CHRONOS, SOLO-CONTINUE, and CAFÉ.

In the US, Dupixent is approved to treat adults with moderate to severe AD that is not controlled well with prescription therapies used on the skin (topical), or those who cannot use topical therapies.

The drug is currently being evaluated in studies in children with severe AD and adolescents with moderate to severe AD, as well as those with other inflammatory diseases such as uncontrolled persistent asthma (Phase III), nasal polyposis (Phase III), and eosinophilic esophagitis (Phase II).