URHAM, N.C.– Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for oteseconazole, an oral antifungal product for the treatment of recurrent vulvovaginal candidiasis (RVVC). Also known as chronic yeast infection, RVVC is a distinct condition from vulvovaginal candidiasis (VVC) and defined as three or more symptomatic acute episodes of yeast infection per year. RVVC affects nearly 138 million women worldwide each year and 6 million women in the U.S. alone. There are currently no FDA-approved treatments.
The FDA previously granted oteseconazole Priority Review, which is a designation reserved for potential drugs that, if approved, would mark significant improvements in the safety or effectiveness in the treatment of serious conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA set a six-month period with a target action date of January 27, 2022.
Mycovia’s NDA for oteseconazole is supported by positive results from three Phase 3 trials – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including more than 870 patients at 232 sites across 11 countries. Both VIOLET studies met their primary and key secondary endpoints. Additionally, results from ultraVIOLET demonstrated oteseconazole’s effectiveness in treating the initial episode of VVC and reinforced its efficacy and safety profile in treating RVVC as compared to fluconazole, the current standard of care for VVC. Combined Phase 3 data showed that oteseconazole protected more than 90% of participants from having a recurrence for nearly a year.
“RVVC is a different condition from yeast infections, simply known as VVC, so it requires a different treatment,” said Patrick Jordan, CEO of Mycovia Pharmaceuticals and Partner at NovaQuest Capital Management, which formed Mycovia in 2018. “Research shows that fluconazole, the standard of care for VVC, is more than 90% effective in treating an initial episode of VVC1, but in studies of patients with RVVC, greater than 50% of women experience a recurrence following maintenance therapy discontinuation2.”
“We designed oteseconazole to address this need as a highly selective targeted oral therapy that demonstrates improved efficacy with fewer side effects than current treatment options, including fluconazole,” Jordan continued. “Supported by rigorous clinical trials evaluating the safety and efficacy of oteseconazole, we are eager for the FDA to review the application for our product, which has the potential to be the first FDA-approved therapy indicated for RVVC.”
Oteseconazole was granted Qualified Infectious Disease Product (QIDP) and Fast-Track designations by the FDA. With this timeline and pending full FDA review and approval, Mycovia is preparing for a U.S. launch of oteseconazole in early 2022.
