The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the New Drug Application (NDA) for ibrexafungerp (SCY-078; Scynexis) for the treatment of vulvovaginal candidiasis.

Ibrexafungerp is an investigational oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids. It has been shown to have broad spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.

The NDA is supported by data from 2 multicenter, randomized, double-blind, placebo-controlled phase 3 studies (VANISH-303 and VANISH-306) that compared the efficacy and safety of ibrexafungerp to placebo in female patients aged 12 years and older with acute vulvovaginal candidiasis. Both trials showed that ibrexafungerp was statistically superior to placebo with regard to the primary end point of clinical cure, defined as the complete resolution of all signs and symptoms at the test-of-cure visit on day 10.

As for safety, gastrointestinal side effects made up the majority of adverse events in patients treated with ibrexafungerp. The 3 most common GI events were diarrhea/loose stool, nausea and abdominal pain.

A Prescription Drug User Fee Act (PDUFA) target date of June 1, 2021 has been set for this application.

“The acceptance of this NDA marks a major milestone toward our goal of bringing to market the first new class of antifungals in over 20 years and the first new oral treatment in more than 25 years to the millions of women suffering from vaginal yeast infections,” said Marco Taglietti, MD, President and CEO of Scynexis. “As the first oral, non-azole treatment for this particularly symptomatic condition, we believe ibrexafungerp has the potential to change the antifungal treatment landscape.”

The FDA previously granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to ibrexafungerp for the treatment of vulvovaginal candidiasis.

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Scynexis announces FDA acceptance and priority review of New Drug Application for oral ibrexafungerp for the treatment of vaginal yeast infections. [press release]. Jersey City, NJ: Scynexis, Inc; December 7, 2020.