The Food and Drug Administration (FDA) has approved Brexafemme (ibrexafungerp) for a second indication for reduction in incidence of recurrent vulvovaginal candidiasis, Scynexis announced Thursday
“Brexafemme was already the only non-azole oral therapy available for VVC and is now the only therapy FDA-approved for both VVC and RVVC,” said Marco Taglietti, M.D., President and Chief Executive Officer of Scynexis.
The FDA accepted the application for the second use last summer and the approval followed positive results from a trial that showed 65.4% of patients had no recurrence of yeast infection vs. 53.1% in a placebo group after a three-month follow-up period.
The most common adverse responses were headache or gastrointestinal and were mostly mild, the company reported.
With the FDA approval, the tablets can now be prescribed for patients with both VVC and RVCC.