PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNYNF, SNY) Thursday said the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy designation to its investigational dupilumab, which is indicated for the treatment of adults with moderate-to-severe atopic dermatitis or AD, who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.
The decision was based on positive results from Phase 1 and 2 clinical trials.
Breakthrough Therapy designation facilitates development and review of drugs that target serious or life-threatening conditions
Currently, a Phase 3 worldwide clinical trial of dupilumab in adults with moderate-to-severe AD is ongoing.
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