FDA accepts sNDA and gives priority review to Brexafemme in vulvovaginal candidiasis
Scynexis announced that the FDA has accepted the Company’s submission of a supplemental New Drug Application (sNDA) to expand the label of Brexafemme (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC)
The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022.
If approved for this second indication, Brexafemme, an oral non-azole therapy, would be the first and only product approved in the U.S. for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of RVVC, defined as three or more infections in a 12-month period.
The approval was supported by positive results from two Phase III, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. Brexafemme represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole.
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