FDA approve Dupixent for moderate-to-severe AD

Sanofi and Regeneron Pharmaceuticals have announced that the US FDA has approved Dupixent (dupilumab) injection, which is the first targeted biologic therapy for adults suffering from moderate-to-severe atopic dermatitis (AD) who have uncontrolled disease.

AD is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe AD is characterised by rashes often covering much of the body and can include intense, persistent itching and skin dryness, cracking, redness, crusting and oozing.

Dupixent is a human monoclonal antibody that is 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 treatment comes in a pre-filled syringe and can be self-administered by patients as a subcutaneous injection every other week after an initial loading dose.

“People with moderate-to-severe AD cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” said Julie Block, president and CEO of the National Eczema Association. “To date, there have been few options available to treat people with moderate-to-severe AD who have uncontrolled disease.”

George D. Yancopoulos, MD, PhD, founding scientists, president and chief scientific officer at Regeneron, stated, “Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases. In AD, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease.”