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Scynexis announced that the US FDA has approved the innovative oral glucan synthase inhibitor Brexafemme (ibrexafungerp) for the treatment of vulvovaginal candidiasis (VVC, also known as vaginal yeast infection).
Brexafemme is a "first-in- class" triterpene antifungal agent
.
The press release pointed out that Brexafemme is the first innovative antifungal drug type approved in more than 20 years and the first non-azole therapy for the treatment of vaginal yeast infections
This is also the 25th new drug approved by the US FDA this year, surpassing the total number of new drugs approved in the first half of last year (24 models) and setting a new high in the first half of the past 10 years
.
Its approval is based on the positive results of two phase 3 clinical studies, which showed that the drug once a day orally once a day showed significant efficacy and good tolerability in patients with VVC
.
After 10 days of treatment, 63.
VVC is an inflammatory disease caused by fungal infection
.
The main pathogenic bacteria is Candida albicans .
Brexafemme is a new type of glucan synthase inhibitor, which combines the good activity of glucan synthase inhibitor with the potential flexibility of oral and intravenous administration, and is expected to be widely used in inpatient and outpatient settings
.
Currently, the drug is being developed to treat fungal infections mainly caused by Candida and Aspergillus