Sanofi and Regeneron Announce Approval of Dupixent® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis in the European Union

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for Dupixent® (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) 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.[i],[ii],[iii],[iv] 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.[v],[vi] Itch is one of the most burdensome symptoms for patients and can be debilitating.7 In addition, people with moderate-to-severe atopic dermatitis experience impaired quality of life, including disrupted sleep, and increased anxiety and depression symptoms along with their disease.[vii]

“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 Organizations. “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.”

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, and certain other allergic or atopic diseases.[viii],[ix] Dupixent will come in a pre-filled syringe and can be self-administered by a patient as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids.8

“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 Elias Zerhouni, M.D., 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.”

Following the granting of this marketing authorization, Sanofi and Regeneron will work with relevant local authorities to make Dupixent available to patie