FDA Approves First Drug for Recurrent Yeast Infections
- Select a language for the TTS:
- UK English Female
- UK English Male
- US English Female
- US English Male
- Australian Female
- Australian Male
- Language selected: (auto detect) - EN
Play all audios:
The FDA gave the green light to oteseconazole (Vivjoa), making it the first approved medication to treat chronic yeast infections, manufacturer Mycovia Pharmaceuticals announced on Thursday.
Due to embryo-fetal toxicity risks, however, the oral drug is indicated for recurrent vulvovaginal candidiasis (RVVC) only in women who are permanently infertile or postmenopausal. In its
press release, Mycovia noted that the CDC defines RVVC as three or more symptomatic acute episodes of yeast infection within 12 months.
Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity; this interaction is also toxic to fungi, leading to the inhibition of fungal growth.
Approval was based on a trio of phase III trials -- two global trials (called VIOLET) and one in the U.S. (ultraVIOLET) -- comprising 875 patients across 11 countries.
In the VIOLET studies, a significantly higher proportion of women randomized to receive the intervention reported no RVVC recurrence during the 48-week maintenance period versus those who
received placebo (93.3% vs 57.2% and 96.1% vs 60.6%; P