US biotech Scynexis (Nasdaq: SCYX) has partnered with Amplity Health in connection with the anticipated US launch of Brexafemme (ibrexafungerp).
Amplity, a leading global contract commercialization organization, specializes in designing, implementing, and managing customer facing and inside sales, service, medical and clinical teams. Brexafemme is the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection.
The New Drug Application (NDA) for Brexafemme is under review by the US Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021. If approved, Brexafemme would represent the first novel antifungal class in over 20 years and would be the first and only non-azole treatment for vaginal yeast infections, in which case, the company expects a second-quarter 2021 launch/
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