FDA Approves Vivjoa for Chronic Yeast Infections

Vivjoa is an oral therapy and the first for chronic yeast infections. It is expected to be available in the second quarter of 2022.

The FDA has approved Vivjoa (oteseconazole capsules), an azole antifungal to reduce the incidence of chronic yeast infection in postmenopausal women. This is the first approval for Mycovia Pharmaceuticals, which is developing therapies for fungal infections.

Recurrent vulvovaginal candidiasis is defined as three or more acute episodes of yeast infection in 12 months. It is considered a distinct condition from vulvovaginal candidiasis and until now, there have been no FDA-approved medications specifically indicated for it.

Nearly 75% of all adult women will have at least one yeast infection in their lifetime, with about half experiencing a recurrence. Of those, up to 9% develop recurrent infections.

The approval is based on the positive results from three phase 3 trials of Vivjoa — two global, pivotal studies and one U.S.-focused study, that included a total of 875 patients. In the two global VIOLET studies, 93.3% and 96.1% of women with recurrent vulvovaginal candidiasis who received Vivjoa did not have a recurrence for the 48-week maintenance period compared with 57.2% and 60.6% of patients who received placebo.

In the ultraVIOLET study, 89.7% of women with recurrent vulvovaginal candidiasis who received Vivjoa cleared their initial yeast infection and did not have a recurrence for the 50-week maintenance period compared with 57.1% of those who received fluconazole followed by placebo.

Vivjo is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this results in the inhibition of fungal growth.