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FDA Provides PDUFA Date for Ibrexafungerp

This regulatory review is for the prevention of recurrent vaginal yeast infections. And if approved, it would be a second indication for the antifungal related to these infections.

The Food and Drug Administration (FDA) has granted a priority review to expand the label of ibrexafungerp (Brexafemme) to include the prevention of recurrent vulvovaginal candidiasis (RVVC). This antifungal, which is manufactured by Scynexis, was given a Prescription Drug User Fee Act (PDUFA) target date of November 30, 2022.

The FDA approved ibrexafungerp in June of last year for VVC treatment. The therapy, which represented 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.

If approved for this second indication, ibexafungerp, a non-azole therapy, would be the first and only product approved in the United States for both the treatment of VVC and the prevention of RVVC.

“The FDA’s acceptance of this submission is excellent news for patients, and it brings us another step closer to our vision of addressing significant unmet needs in women’s health,” Marco Taglietti, MD, president and CEO of Scynexis, said in a statment. “Our pivotal CANDLE study was the basis of the sNDA submission, and we look forward to presenting details of these data to the medical community.”

In the CANDLE study, topline data demonstrated that 71% of patients (17 of 24) with RVVC who failed to respond to a 3-day regimen of fluconazole achieved a substantial reduction or complete elimination of signs and symptoms after receiving a 1-day treatment with ibrexafungerp.

This study was an open-label sub-study enrolled 24 patients who failed to respond to an initial three-doses of fluconazole given over 7 days. Fluconazole failure was defined as persistent vaginal signs and symptoms (VSS) score equal to or greater than three after therapy. Participants received a 1-day treatment of ibrexafungerp (300 mg BID).

The company has also been studying ibrexafungerp for the treatment of Candida auris, a life-threatening invasive fungal infection that develops in hospitalized patients and people living in long term care facilities.