FDA approves first medication for chronic yeast infection
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The FDA has approved Vivjoa — the first medication for recurrent vulvovaginal candidiasis — for use in permanently infertile and postmenopausal women, according to a Mycovia Pharmaceuticals press release.
The oteseconazole capsules are the first medication developed for the treatment of recurrent vulvovaginal candidiasis (RVVC), which is a specific form of VVC that is defined by the occurrence of three or more acute yeast infection episodes within 12 months.
Vivjoa has shown long-term efficacy in RVVC in three phase 3 trials, with the most common side effects being headache and nausea. According to the press release, the medication should not be used by pregnant or lactating women, or by those with reproductive potential.
“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,” Patrick Jordan, CEO of Mycovia and partner at NovaQuest Capital Management, said in the release. “We are honored to lead this advancement in women’s health.”
Mycovia plans to launch Vivjoa during the second quarter of 2022.