The small biopharma Mycovia Pharmaceuticals has notched its first FDA approval with Vivjoa (oteseconazole), a novel drug for treating recurrent vulvovaginal candidiasis (yeast infections).
The Durham, North Carolina-based company plans to launch the drug in the U.S. in the second quarter of the year. Vivjoa is an azole antifungal indicated for females with recurrent vulvovaginal candidiasis (RVVC) who are post-menopausal or otherwise infertile.
Specifically, the indication covers women with at least three symptomatic acute episodes of yeast infection within 12 months.
Before the approval of Vivjoya, there was no FDA-approved option for specifically treating RVVC.
Anywhere from 29% to 49% of women have had a healthcare provider-diagnosed vaginal yeast infection in their lifetime, according to an analysis in the Journal of Lower Genital Tract Disease. According to the study, at least one-fifth of the subjects suffered from recurring infections withi…