SLGL - FDA approves Sol-Gel Technologies' TWYNEO to treat acne vulgaris

Bet_Noire/iStock via Getty Images The U.S. FDA has approved Sol-Gel Technologies' ([[SLGL]]) TWYNEO (tretinoin/benzoyl peroxide) cream, 0.1%/3%, for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. TWYNEO, which is patent protected until 2038, was approved based on positive results from two late-stage, randomized, double-blind, vehicle-controlled, multi-center studies. Sol-Gel has partnered with Galderma to commercialize TWYNEO in the U.S. The company expects to receive a regulatory milestone payment in conjunction with the approval and retains the option to regain U.S. commercialization rights five years following first commercialization in the region. Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects up to 50M people in the U.S.

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FDA approves Sol-Gel Technologies' TWYNEO to treat acne vulgaris