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SCYNEXIS Announces Submission Of New Drug Application To FDA For Oral Ibrexafungerp For 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 disease product (QIDP), ibrexafungerp is

· 10/14/2020 08:33
  • 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.

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 space to meet the needs of women who are not satisfied with the existing, azole-class treatments. Based on ibrexafungerp’s unique collection of attributes, such as a differentiated mechanism of action which, unlike the azoles, enables killing of the fungus, we believe our new treatment has significant potential in this segment. If approved, we are confident that we can successfully execute on our commercialization strategy and capture a meaningful percentage of the VVC addressable market.”

Ibrexafungerp has been granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA. Under QIDP status, ibrexafungerp is also eligible to receive priority review, which can expedite the review process to six months following acceptance of the NDA submission. Additionally, under QIDP designation, ibrexafungerp is eligible for an additional five years of market exclusivity.