FDA approves novel oral treatment for vulvovaginal candidiasis
The FDA this week approved Scynexis’s novel 1-day oral treatment for vulvovaginal candidiasis, ibrexafungerp, making it the first approved drug in a novel antifungal class in more than 20 years, the company said.
“We are pleased to bring this much-needed innovation to the antifungal field and to offer a new 1-day oral antifungal treatment for vaginal yeast infections to millions of women who could benefit from a new therapeutic option,” Scynexis Chief Medical Officer David Angulo, MD, said in a press release.
The approval was backed by two phase 3, double-blind, placebo-controlled trials that showed the drug was effective among women with vulvovaginal candidiasis, with a favorable tolerability profile.
Scynexis said it will partner with Amplity Health to commercialize the drug, now branded Brexafemme, with a commercial launch scheduled for later this year.
“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,” Marco Taglietti, MD, president and CEO of Scynexis, said in the release.
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Press Release.