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Dupilumab granted FDA breakthrough therapy designation
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Regeneron Pharmaceuticals and Sanofi announced that the U.S. Food and Drug Administration has granted breakthrough therapy designation to dupilumab for adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy or for whom such treatments are not appropriate.
The designation is based on positive results from phase 1 and 2 clinical trials, according to a Regeneron press release.
Dupilumab is an investigational therapy that blocks interleukin 4 (IL-4) and IL-13, two cytokines required for type 2 helper T cell immune response.
Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions.
A phase 3 worldwide clinical program for dupilumab in adults with moderate-to-severe atopic dermatitis is ongoing, according to the release. For more information, visit www.clinicaltrials.gov.