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SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections
Approval of BREXAFEMME (ibrexafungerp) represents the first approved drug in a novel antifungal class in more than 20 yearsBREXAFEMME, a one-day oral
About this update from Scynexis, Inc.
[{"type":"text","content":"Approval of BREXAFEMME (ibrexafungerp) represents the first approved drug in a novel antifungal class in more than 20 yearsBREXAFEMME, a one-day oral treatment for vaginal yeast infection, is the first FDA-approved indication of the ibrexafungerp development pipelineU.S. commercial launch expected in the second half of 2021 in partnership with Amplity Health, marking the evolution of SCYNEXIS to a commercial-stage antifungal companyLeveraging 14 years of patent protection, SCYNEXIS continues to advance its pipeline of ibrexafungerp indications to create a long-lasting antifungal franchise in both hospital and community settingsSCYNEXIS to host a conference call today at 8:30 a.m. ET JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. BREXAFEMME, which represents the first approved drug in a novel antifungal class in more than 20 years, 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, a leading global contract commercialization organization, to support U.S. commercialization of BREXAFEMME, with commercial launch scheduled in the second half of this year. “The FDA approval of BREXAFEMME is the culmination of years of work and a significant milestone for SCYNEXIS, marking our evolution to a commercial-stage antifungal company. We are pleased with the approved label, highlighting the unique attributes of BREXAFEMME, and thrilled to be able to offer a new treatment option to women with vaginal yeast infections,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We believe ibrexafungerp has significant commercial potential. This first approval in the U.S. is a major step towards building the ibrexafungerp antifungal franchise as we intend to leverage an extended 10-year period of regulatory exclusivity and 14 years of patent protection. We are in a strong financial ...