FDA approved this year's 25th new drug approval speed hits a record high over the same period

On June 2, 2021, Scinexis announced that the US FDA has approved Brexafemme (ibrexafungerp), an innovative oral glucan synthase inhibitor, for the treatment of vulvovaginal candidiasis (VVC, also known as vaginal yeast infection).

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), 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.

VVC is an inflammatory disease caused by fungal infection.

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.

▲Brief introduction of Brexafemme (ibrexafungerp) (picture source: Scynexis official website)

Note: The original text has been deleted

Reference materials:

[1] SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections.

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