The European Commission (EC) has granted marketing authorisation to Sanofi and Regeneron Pharmaceuticals for dupilumab (Dupixent) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
Regulatory approval
Dupixent, a human monoclonal antibody, has been designed to specifically inhibit overactive signalling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. The therapy will be delivered in a pre-filled syringe for self-administration by the patient as a subcutaneous injection every other week after an initial loading dose. It can be used with or without topical corticosteroids.
“People with moderate-to-severe atopic dermatitis can experience unbearable symptoms that may significantly impact their quality of life. Many often struggle to control their disease with the treatment options currently available,” said Christine Janus, chief executive officer of the International Alliance of Dermatology Patient Organisations. “We support timely access to this important new medication for those with moderate-to-severe atopic dermatitis to help them control and provide relief for this life-altering, often severely debilitating, chronic disease.”
“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,” said Dr Elias Zerhouni, president, Global R&D, Sanofi. “Dupixent targets an underlying cause of atopic dermatitis, helps clear the skin, manage the persistent debilitating itch, and improve 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.”
“Dupixent represents the culmination of decades of our scientific research into the biology of allergic diseases such as moderate-to-severe atopic dermatitis,” said Dr George D. Yancopoulos, PhD, president, and chief scientific officer, Regeneron. “We continue to evaluate the potential of dupilumab in the treatment of atopic dermatitis in children and adolescents as well as other allergic inflammatory diseases driven by the IL-4/IL-13 pathway.”
Following this marketing authorisation, Sanofi and Regeneron will work with relevant local authorities to make this therapy available to patients.