FDA approves first drug for RVVC

The US Food and Drug Administration (FDA) has approved oteseconazole (Vivjoa; Mycovia Pharmaceuticals) to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC), commonly referred to

as chronic yeast infection, in women with a history of RVVC who are not of reproductive potential, according to a company press release announcing the approval.¹

This approval makes oteseconazole the first and only medication approved by the FDA for RVVC. Additionally, this is Mycovia’s first product approved by the FDA.

Oteseconazole is a medication intended to inhibit fungal CYP51, which is required for fungal cell wall integrity. This interaction is also toxic to fungi, which results in the inhibition of fungal growth. Oteseconazole has a lower affinity for human CYP enzymes compared to fungal CYP enzymes due to its chemical structure. Previously, the FDA granted oteseconazole Qualified Infectious Disease Product and Fast Track designations.

“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, a patient with RVVC and clinical trial participant. “It is gratifying to see RVVC finally get the attention it deserves.”

The decision was based on positive results from 3 phase 3 clinical trials investigating oteseconazole—2 global VIOLET studies (NCT03561701 and NCT03562156) and 1 US-based ultraVIOLET (NCT03840616) study which comprised 875 patients at 232 sites across 11 countries.

In the VIOLET studies, 93.3% and 96.1% of RVVC patients who received oteseconazole did not have a recurrence during the 48-week maintenance period vs 57.2% and 60.6% of patients who received placebo (P <0.001).

In the ultraVIOLET study, 89.7% of RVVC patients who received oteseconazole displayed clearance of their initial infection and did not experience recurrence during the 50-week maintenance period vs 57.1% of patients who received fluconazole followed by placebo (P <0.001).

Commonly reported side effects in the phase 3 trials included headache (7.4%) and nausea (3.6%). It is important to note that oteseconazole is contraindicated in patients with a hypersensitivity to the medication, based on data collected from rat studies. The medication is also contradicted in females who pregnant, lactating, or who are of reproductive potential.

“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,” stated Stephen Brand, PhD, chief development officer of Mycovia. “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.”

According to a company press release, Mycovia plans on commercially launching oteseconazole during the second quarter of 2022.

Reference

1. FDA approves Mycovia Pharmaceuticals’ Vivjoa (oteseconazole), the first and only FDA-approved medication for recurrent vulvovaginal candidiasis (chronic yeast infection). Published online April 28, 2022. Accessed April 29, 2022. https://mycovia.com/wp-content/uploads/2022/04/FINAL-Press-Release_04.28.22.pdf