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 within 12 months. The analysis considered data from the U.S. and Europe.
To win approval, Mycovia submitted positive data from three Phase 3 studies.
“We believe the market need for Vivjoya is strong, and we are eager to execute our commercial plans,” said Patrick Jordan, CEO of Mycovia Pharmaceuticals, in a statement. “As we enter a new chapter of our history as a commercial biopharmaceutical company, we will continue driving our mission forward to develop novel therapies for overlooked conditions.”
In July 2021, Mycovia won a priority review of the new drug application for oteseconazole from FDA.
Filed Under: Obstetrics & gynecology