FDA Approves Ibrexafungerp
This is the first oral non-azole treatment for vaginal yeast infections.
The FDA has approved Brexafemme (ibrexafungerp) for treatment of vulvovaginal candidiasis (VVC). The therapy was developed by Jersey City, NJ-based Scynexis.
The therapy, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from 2 phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.
“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,” Scynexis CEO Marco Taglietti, MD, said. “We believe ibrexafungerp has significant commercial potential. This first approval in the US 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.”
Data from their phase 3 VANISH program, which had its VANISH 306 AND VANISH 303 studies, showed ibrexafungerp met its endpoints and achieved statistically significant superiority vs. placebo. In its VANISH 306 study, 188 participants were in the treatment arm and 84 were placed in the placebo group. In its VANISH 303 study, 188 participants were in the treatment arm and 98 were placed in the placebo group.
The company is also studying ibrexafungerp in its CARES study program for life-threatening fungal infections such as Candida auris in hospitalized patients.
“We are in a strong financial position to execute on our commercial plans and are committed to advancing our hospital programs to maximize the broad potential of this novel therapeutic class to help patients with serious and often resistant fungal infections,” Taglietti said.
Scynexis has partnered with Amplity Health to support the US commercialization of ibrexafungerp with a potential launch scheduled in the second half of this year.
