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HomeFDA Approvalsindex/list_13473_1FDA Approves Oteseconazole for Chronic Yeast Infections

FDA Approves Oteseconazole for Chronic Yeast Infections

The US Food and Drug Administration (FDA) has approved oteseconazole capsules (Vivjoa), an azole antifungal agent for the prevention of recurrent yeast infections in females who are not of reproductive potential.

Oteseconazole inhibits CYP51, an enzyme fungi require to preserve the integrity of their cell walls and to grow properly, according to Mycovia, the drug’s manufacturer. It is the first FDA-approved product for the treatment of recurrent vulvovaginal candidiasis (RVVC).

Recurrent vulvovaginal candidiasis, or chronic yeast infection, affects an estimated 138 million women worldwide annually. The condition is defined as three or more symptomatic acute episodes of yeast infection within a 12-month period. The primary symptoms of RVVC include vaginal itching, burning, irritation, and inflammation. Some patients also may experience abnormal vaginal discharge and pain during sex or urination.

“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, chief development officer of Mycovia, said in a statement. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”

Approval for oteseconazole was based on results of three phase 3 trials involving 875 patients at 232 sites across 11 countries. In  the US-only ultraVIOLET trial, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and did not experience a recurrence during the 50-week maintenance period compared to 57.1% of those who received fluconazole (Diflucan) followed by placebo (P < .001), according to Mycovia.

The most common side effects reported in phase 3 clinical studies were headache (7.4%) and nausea (3.6%), the company said. Patients with a hypersensitivity to oteseconazole should not take the drug, nor should those who are of reproductive potential, pregnant, or lactating.

Mycovia said it plans to launch the drug in the second quarter of 2022.

Full prescribing information is available online.

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