Regeneron and Sanofi granted breakthrough designation for dupilumab

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN) have said that the US Food and Drug Administration has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD).

Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response. The indication is for patients whose AD is not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. The designation is based on positive results from Phase I and II clinical trials. A Phase III worldwide clinical program for dupilumab in adults with moderate-to-severe atopic dermatitis is on-going.

Julie Block, chief executive of the National Eczema Association, said: "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. We are thrilled to see the FDA recognizing the need to expedite and prioritize potential new options for these patients."