Oteseconazole first FDA approved drug for recurrent vulvovaginal candidiasis
USA: The US Food and Drug Administration (FDA) has given approval to oteseconazole (Vivjoa), making it the first medication to be approved for chronic yeast infections treatment.
The oral drug however is indicated for recurrent vulvovaginal candidiasis (RVVC) only in women who are permanently infertile or postmenopausal due to embryo-fetal toxicity risks. In its press release, manufacturer Mycovia Pharmaceuticals noted that CDC defines RVVC as three or more symptomatic acute episodes of yeast infection within 12 months.
Oteseconazole is designed for inhibiting fungal CYP51 which is required for the integrity of fungal cell walls; this interaction is also toxic to fungi, leading to the inhibition of fungal growth.
The FDA 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.
Based on the trial, the researchers reported the following findings:
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