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▎WuXi AppTec content team editor Recently, the FDA's official website shows that the FDA has approved the oral antifungal drug Vivjoa (oteseconazole) developed by Mycovia Pharmaceuticals for the reduction of recurrent vulvovaginal Candida in women of no reproductive potential.
Recurrence of disease (RVVC)
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Previously, Mycovia noted in a press release that, if approved, oteseconazole would be the first FDA-approved drug for the treatment of RVVC
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It is worth mentioning that Hengrui Medicine introduced this new antifungal drug from Mycovia Pharmaceuticals
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In January this year, Hengrui Medicine has submitted its new drug marketing application in China
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Image source: FDA's official website RVVC, also known as chronic yeast infection, is usually defined as acute episodes of symptomatic yeast infections that occur more than 3 times per year in patients
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Its main symptoms include vaginal itching, burning, irritation and inflammation
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Some patients also experience abnormal vaginal discharge and pain during intercourse or urination
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RVVC affects nearly 138 million women worldwide each year, with approximately 29 million RVVC patients in China, for which there is currently no approved therapy
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This approval is supported by positive results from three Phase 3 clinical trials, including two global VIOLET trials and one ultraVIOLET trial in the United States, enrolling more than 870 patients
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Both VIOLET trials met their primary and key secondary endpoints
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In the 48-week trial, more than 90% of patients treated with oteseconazole were effective in preventing recurrence of infection (p<0.
001)
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▲ Molecular formula of Oteseconazole (Image source: PubChem) In addition, the ultraVIOLET trial also met all of its primary endpoints and key secondary endpoints
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The results of the trial showed that oteseconazole was effective in the treatment of initial episodes of VVC, and further demonstrated its efficacy and safety in the treatment of RVVC compared with the current standard of care
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By 50 weeks, the recurrence rate was 5.
1% in the treatment group and 42.
2% in the control group (p<0.
001)
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Also, oteseconazole protected 95% of subjects from relapse for nearly one year
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It is expected that this new drug will bring new treatment options to female patients
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Reference: [1] Drugs@FDA: FDA-Approved Drugs.
Retrieved April 27, 2022, from https:// 215888 Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
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This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
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This article is also not a treatment plan recommendation
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For guidance on treatment options, please visit a regular hospital
.