Regeneron and Sanofi Announce that Dupilumab Has Received FDA Breakthrough Therapy Designation in Atopic Dermatitis

Regeneron Pharmaceuticals and Sanofi have announced that the FDA has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response. The designation is based on positive results from Phase I and II clinical trials.

"Moderate-to-severe atopic dermatitis is a debilitating, life-altering disease with very limited treatment options. Many patients suffer for years with widespread inflamed skin, intense itch, sleep disturbances and other challenges," said Julie Block, CEO, National Eczema Association. "We are thrilled to see the FDA recognising the need to expedite and prioritise potential new options for these patients."

Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions. A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy. The designation includes all of the Fast Track programme features, as well as more intensive FDA guidance and discussion. The Breakthrough Therapy designation is distinct from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.

A Phase III worldwide clinical programme for dupilumab in adults with moderate-to-severe atopic dermatitis is ongoing.