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Vivjoa, approved by the FDA in April 2022, is an oral therapy and the first for chronic yeast infections.
Mycovia Pharmaceuticals has launched Vivjoa (oteseconazole) capsules, an azole antifungal to reduce the incidence of chronic yeast infection in postmenopausal women. This is the first approval for Mycovia, which is developing therapies for fungal infections.
The company is offering a patient support program, My VIVJOA, powered by vitaCare, to help patients with insurance coverage support, accessing savings and ongoing education. VitaCare is a technology and services platform that helps patients navigate key access and adherence barriers for branded medications. VitaCare will help patients understand and verify insurance coverage, identify available savings opportunities, assist providers in their communication with payors, and offer a seamless path for filling the VIVJOA prescription primarily through an appropriate mail order or local pharmacy.
Vivjoa is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this results in the inhibition of fungal growth.
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.