FDA Approves Mycovia’s Antifungal Drug for Chronic Yeast Infection
Durham-based Mycovia Pharmaceuticals has received its first product approval from the U.S. Food and Drug Administration.
The FDA granted marketing clearance for VIVJOA (oteseconazole capsules), an oral antifungal capsule for treating recurrent vulvovaginal candidiasis (RVVC) in females with a history of the infection who are beyond their reproductive capacity.
VIVJOA is the first and only FDA-approved medication for this condition and provides sustained efficacy, demonstrated by significant long-term reduction of RVVC recurrence through 50 weeks versus other treatments, the company said in a news release.
“We celebrate this important milestone for Mycovia, as VIVJOA is the first antifungal in our pipeline to obtain FDA approval and achieves our goal to fulfill a previously unmet medical need among women suffering from RVVC,” said Patrick Jordan, chief executive officer of Mycovia and partner at NovaQuest Capital Management, a Raleigh-based life sciences investment firm that has funded Mycovia.
Drug meets ‘strong need’
RVVC, also known as chronic yeast infection, is defined by the Centers for Disease Control and Prevention as three or more symptomatic acute episodes of yeast infection in 12 months. 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 women, up to 9% develop RVVC.
“After nearly two decades of living with chronic yeast infection and feeling like there was no hope from the itchiness, irritation and constant dread of when the next yeast infection would return, I was overjoyed to even be a part of this clinical trial,” said Leslie Ivey, an RVVC patient and clinical trial participant. “It is gratifying to see RVVC finally get the attention it deserves.”
Symptoms of RVVC include vaginal itching, burning, irritation and inflammation. Some women may experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain.
“We believe the market need for VIVJOA is strong, and we are eager to execute our commercial plans,” Jordan said. “As we enter a new chapter of our history as a commercial biopharmaceutical company, we will continue driving our mission forward to develop novel therapies for overlooked conditions.”
The company said it expected to commercially launch VIVJOA in the United States in the second quarter of this year.
Dosing details are as follows: On the first day take 600 milligrams (as a single dose). Then a week later, take 450 mg (as a single dose). Then a week after that, take a 150 mg capsule every seven days for 11 weeks (weeks two through 12).
In 2019, Mycovia licensed the drug to Jiangsu Hengrui Pharmaceuticals to develop and commercialize it in China, including mainland China, Hong Kong, Macau and Taiwan, and to Gedeon Richter, a Hungary-based pharmaceutical company, to commercialize and manufacture it in Europe, Russia, the Commonwealth of Independent States, Latin America and Australia.
Three successful clinical trials
FDA approval of VIVJOA was based on the positive results from three Phase 3 trials involving 875 patients at 232 sites across 11 countries.
In two global studies, 93.3% and 96.1% of women with RVVC who received VIVJOA did not have a recurrence for the 48-week maintenance period compared to 57.2% and 60.6% of patients who received placebo, according to the company. In a U.S. study 89.7% of women with RVVC who received VIVJOA cleared their initial yeast infection and did not have a recurrence for the 50-week maintenance period compared to 57.1% of those who received fluconazole followed by placebo.
VIVJOA is an azole antifungal, a class of drugs that deter yeasts and fungi by blocking enzymes vital to their cell membranes. Damage to the membranes kills the cells.
The drug is intended for women with RVV who are permanently infertile and postmenopausal.
Mycovia was founded in 2018 following the acquisition of Viamet Pharmaceuticals by NovaQuest Capital Management.
In addition to VIVJOA, the company is developing other antifungals for valley fever, cryptococcal meningitis, emerging multi-drug resistant fungi and onychomycosis, a common infection of the toenails or fingernails.