FDA approves first-ever atopic dermatitis biologic treatment

Sanofi and Regeneron’s Dupixent (dupilumab) has become the first biologic medicine to be approved by the FDA for the treatment of moderate-to-severe atopic dermatitis (AD), the most common form of eczema, in adults when topical prescription therapies are ineffective or inadvisable.

An injectable human monocloncal antibody, Dupixent functions by inhibiting overactive signalling of IL-4 and IL-13, two key proteins in the development  of persistent underlying inflammation in AD. It can be self-administered every other week and can be used with or without topical corticosteroids.

"People with moderate-to-severe atopic dermatitis 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 atopic dermatitis who have uncontrolled disease.  That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease."

The drug previously earned Breakthrough Therapy Designation from the FDA in 2014, followed by Priority Review. Both companies have also announced they will be launching Dupixent MyWay, a programme designed to support patients throughout the treatment process.

"Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases.  In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease," said George D. Yancopoulos, Founding Scientist, President, and CSO of Regeneron.  "Today’s approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program."

"We strive to transform scientific innovation into therapeutic solutions that make a meaningful difference to people’s lives," added Olivier Brandicourt, Chief Executive Officer, Sanofi. "The approval of Dupixent offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally."

Dupixent is now available, marketed by Regeneron and Sanofi Genzyme in the US.