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SCYNEXIS Announces Submission of New Drug Application to the U.S. Food and Drug Administration for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infection
NDA submission is supported by positive data from two Phase 3 studies (VANISH Program) in women with vulvovaginal candidiasis (VVC)As a qualified infectious
About this update from Scynexis, Inc.
[{"type":"text","content":"NDA submission is supported by positive data from two Phase 3 studies (VANISH Program) in women with vulvovaginal candidiasis (VVC)As a qualified infectious disease product (QIDP), ibrexafungerp is expected to receive a 6-month priority review following NDA acceptance JERSEY CITY, N.J., Oct. 14, 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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oral ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. The submission 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 statistical superiority over placebo with a favorable tolerability profile.\n Based on FDA timelines, the Company expects to receive notification if the NDA has been accepted for filing and substantive review in December 2020. “The submission of this NDA marks the next step toward bringing the first new class of oral antifungals in over 20 years to women suffering from vaginal yeast infections and their healthcare providers, who, to date, have had only one class of medications. I couldn’t be prouder of the entire SCYNEXIS team for its talent, hard work and dedication in completing this major milestone,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “With this submission completed, we now increase our focus on the ongoing preparations for a successful commercial launch of ibrexafungerp in the U.S. and advancing our ongoing clinical trials of ibrexafungerp in hospitalized patients with serious and often resistant fungal infections. We believe that ibrexafungerp may be the modern antifungal therapy, that will have utility for a broad range of today’s fungal infection patients as fluconazole did almost 30 years ago.” Jim Maffezzoli, Vice President of Marketing and Sales, added, “The vaginal yeast infection market is well-established and growing, with over 16 million prescriptions written and 18 million over-the-counter units sold annually. For decades, however, there has been a lack of innovation in this spa...