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SCYNEXIS Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections
6-month Priority Review granted for ibrexafungerp with PDUFA target action date set for June 1, 2021 FDA indicated that it is not currently planning to hold
About this update from Scynexis, Inc.
[{"type":"text","content":"6-month Priority Review granted for ibrexafungerp with PDUFA target action date set for June 1, 2021 FDA indicated that it is not currently planning to hold an advisory committee meeting for the applicationSCYNEXIS is continuing preparations for a U.S. commercial launch of ibrexafungerp in 2nd half 2021 JERSEY CITY, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the SCYNEXIS’s New Drug Application (NDA) for ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infections. The FDA has granted this application Priority Review, a designation which is granted to applications for potential drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment of serious conditions when compared to standard applications. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 1, 2021. Additionally, the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application. The NDA is supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated statistically superior efficacy and a favorable tolerability profile in women with VVC. \"The acceptance of this NDA marks a major milestone toward our goal of bringing to market the first new class of antifungals in over 20 years and the first new oral treatment in more than 25 years to the millions of women suffering from vaginal yeast infections,\" said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. \"As the first oral, non-azole treatment for this particularly symptomatic condition, we believe ibrexafungerp has the potential to change the antifungal treatment landscape.” Ibrexafungerp benefits from both Qualified Infectious Disease Product (QIDP) and Fast Track designations granted by the FDA for the treatment of VVC and prevention of recurrent VVC. Under QIDP designation, ibrexafungerp will receive five years of market exclusivity in addition...