FDA Grants Dupilumab Breakthrough Therapy Designation in Atopic Dermatitis

Regeneron Pharmaceuticals, Inc. and Sanofi recently announced the US food and Drug Administration (FDA) granted Breakthrough Therapy designation to dupilumab, a fully-human monoclonal antibody, to treat adults suffering from moderate to severe atopic dermatitis (AD)who had an insufficient response to or who were not suitable for topical prescription therapy.

An investigational therapy that blocks 2 cytokines necessary for Th2 immune response, a critical pathway in allergic inflammation, dupilumab received the Breakthrough Therapy designation based on successful phase one and phase 2 clinical trials from the last year.

The FDA specifically created the Breakthrough Therapy designation in order to accelerate the development and review of drugs, which targeted serious or life-threatening conditions. A Breakthrough Therapy drug is required to exhibit preliminary clinical evidence of a significant level of improvement on a clinically substantial endpoint over available therapies, or over placebo if no therapy is available.

Dupilumab was created largely from Regeneron's innovative VelocImmune® technology and is currently co-developed with Sanofi in atopic dermatitis, asthma, as well as chronic sinusitis with nasal polyposis.

Julie Block, CEO 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.”

As dupilumab is under clinical development, its safety and efficacy have not been fully evaluated by any regulatory authority.It was noted that a Phase 3 worldwide clinical program for dupilumab in adults with moderate-to-severe atopic dermatitis is currently ongoing.