DURHAM – Mycovia Pharmaceuticals has submitted its New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for oteseconazole, an oral antifungal product for the treatment of chronic yeast infection, called recurrent vulvovaginal candidiasis (RVVC), described as three or more episodes per year in a patient, which affects nearly 138 million women globally each year.
The therapy developed by Mycovia was designed to be highly selective for its pathogenic target, the company said, which could result in fewer side effects and enhanced effectiveness compared to other treatment options available.
The company’s clinical development plan included three trials, two global VIOLET studies and one U.S.-focused ultraVIOLET study, including more than 870 patients at 232 sites across 11 countries.
According to the company, both VIOLET studies met their primary and key secondary endpoints and the ultraVIOLET study results demonstrated the therapy’s effectiveness in treating acute episodes. “Combined Phase 3 data showed that oteseconazole protected more than 90% of participants from having a recurrence for nearly a year,” reads a statement issued by the company.
Mycovia COO Thorsten Degenhardt, PhD, notes that there is not a current FDA-approved treatment for recurrent vulvovaginal candidiasis. “We believe, if approved, oteseconazole will provide an important treatment option for healthcare professionals and their patients.”
The company anticipates launching the drug in early 2022, because of oteseconazole’s Qualified Infectious Disease Product (QIDP) and Fast-Track designations, pending full FDA approval.
In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Medicine Co., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan, and Gedeon Richter Plc., a Hungary-based pharmaceutical company, to commercialize and manufacture oteseconazole in Europe, Russia, the Commonwealth of Independent States, Latin America and Australia.
