Mycovia Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for Vivjoa (oteseconazole) for the treatment of recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection for permanently infertile or postmenopausal women. This is the very first approval for a medication for the chronic version of VVC.
The approval is a significant breakthrough for RVVC as it is a condition with significant unmet need.
For Mycovia Pharmaceuticals, Vivjoa is the company’s first FDA-approved drug in its pipeline of novel treatments for fungal infections. North Carolina-based Mycovia is an emerging biopharmaceutical company devoted to recognizing and empowering people living with unmet medical needs through the development of novel therapies.
Almost three out of four women will experience a vaginal yeast infection in their life and half of them will have recurrence. Of those that experience recurrent infection, nine percent will develop RVVC.
While there are various treatments for VVC, the most common form of vaginitis, there has been no FDA-approved treatment for its recurrent form up until now. Last year, the FDA approved ibrexafungerp tablets (Brexafemme) for VVC, the first in a new class of antifungals approved for the condition. Vivjoa is also the second antifungal oral medication approved for vaginal yeast infection — Pfizer’s fluconazole (Diflucan) is the only other FDA-approved oral antifungal for its treatment.
Mycovia’s Vivoja is an azole antifungal in capsule form that is taken orally either alone or in a regimen with fluconazole, according to its prescribing information.
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RVVC is defined by the Centers for Disease Control and Prevention (CDC) as the occurrence of three or more symptomatic acute yeast infections in a span of 12 months.
“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. We are honored to lead this advancement in women’s health,” said Patrick Jordan, CEO of Mycovia Pharmaceuticals and Partner at NovaQuest Capital Management, in a news release from the company.
Oteseconazole is designed to block the action of fungal CYP51, which is an enzyme that plays a crucial role in maintaining fungal cell wall integrity. Inhibiting this function is toxic to fungi and disrupts fungal growth. Oteseconazole has a lower affinity for human CYP enzymes than fungal ones, which means it will have significantly less toxicity against human cells in the body.
The FDA granted oteseconazole Qualified Infectious Disease Product and Fast Track designations.
Oteseconazole’s approval was based on data from three Phase III trials of the drug, which included two global studies called VIOLET and one US ultraVIOLET study. Together, the studies involved 875 patients at 232 sites across 11 countries.
In the global VIOLET studies, 93.3 percent and 96.1 percent of women with RVVC who received oteseconazole did not have a recurrence during a 48-week maintenance period compared to 57.2 percent and 60.6 percent of patients who received placebo (p < 0.001).
In the ultraVIOLET study, 89.7 percent of women with RVVC who received oteseconazole had a clearance of their initial yeast infection and did not have a recurrence in a 50-week maintenance period compared to 57.1 percent of those who received fluconazole followed by placebo (p < 0.001).
Vivjoa is contraindicated in those with a hypersensitivity to oteseconazole as well as females who are of reproductive potential, pregnant or lactating. These contraindications are based on studies in rats.
Vivjoa is gearing up for its commercial launch in the US in the second quarter of 2022.
“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.”