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

  03 June 2021

SCYNEXIS, Inc., a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. BREXAFEMME, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. SCYNEXIS has partnered with Amplity Health, a leading global contract commercialization organization, to support U.S. commercialization of BREXAFEMME, with commercial launch scheduled in the second half of this year.

Further reading: Intrado
Author(s): Scynexis
Smart Innovations  
Back

OUR UNDERWRITERS

Unrestricted financial support by:

LifeArc

Antimicrobial Resistance Fighter Coalition

Bangalore Bioinnovation Centre

INTERNATIONAL FEDERATION PHARMACEUTICAL MANUFACTURERS & ASSOCIATIONS





AMR NEWS

Every two weeks in your inbox

Because there should be one newsletter that brings together all One Health news related to antimicrobial resistance: AMR NEWS!

Subscribe

What is going on with AMR?
Stay tuned with remarkable global AMR news and developments!

Keep me informed