Scynexis : FDA Approves Brexafemme As Oral Non-Azole Treatment For Vaginal Yeast Infections
(RTTNews) – Scynexis Inc. (SCYX) said that the U.S. Food and Drug Administration has approved Brexafemme or ibrexafungerp tablets, for oral use in patients with vulvovaginal candidiasis or VVC, also known as vaginal yeast infection.
Brexafemme 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 said it has partnered with Amplity Health, a global contract commercialization organization, to support U.S. commercialization of Brexafemme, with commercial launch scheduled in the second half of this year.
The company said it is working on completing its CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA in the first half of 2022.
Under Qualified Infectious Disease Product designation, Brexafemme is expected to receive ten years of market exclusivity in the U.S.: five years of new chemical entity exclusivity plus five additional years of exclusivity extension due to the QIDP designation.
Brexafemme is also protected by multiple patents, including a composition-of-matter patent covering the ibrexafungerp molecule. With patent term extension, this patent is expected to expire in 2035, providing 14 years of protection in the U.S.