SCYX - FDA approves SCYNEXIS' BREXAFEMME vaginal yeast infections treatment

SCYNEXIS (SCYX) announces that the U.S. FDA has approved BREXAFEMME (ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis ((VVC)), also known as vaginal yeast infection.BREXAFEMME was approved based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.SCYNEXIS has partnered with Amplity Health to support U.S. commercialization of the treatment, with commercial launch scheduled in the second half of this year.The company also said it expects to submit a supplemental NDA for ibrexafungerp for the prevention of recurrent VVC in the first half of next year.

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FDA approves SCYNEXIS' BREXAFEMME vaginal yeast infections treatment