Mycovia’ Vivjoa (oteseconazole) Receives the US FDA’s Approval for the Treatment of Recurrent Vulvovaginal Candidiasis
Shots:
- The approval was based on 3 P-III trials i.e., two (VIOLET) & 1 US (ultraviolet) study evaluating oteseconazole vs PBO in 875 patients with RVVC at 232 sites across 11 countries. Vivjoa is expected to be available in Q2’22
- The results from 2 (VIOLET) studies showed that (93.3% & 96.1% vs 57.2% & 60.6%) of women achieved a reduction of RVVC recurrence for 48wk. maintenance period. In the (ultraVIOLET) study, 89.7% vs 57.1% of women cleared initial yeast infection & did not have a recurrence for 50wk. maintenance period along with sustained efficacy
- Vivjoa is the 1st US FDA approved product & an azole antifungal that was indicated to reduce the incidence of RVVC in females
Ref: Business wire | Image: Myacovia
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