Fearing cross contamination might have occurred during manufacturing, Scynexis Inc. is recalling Brexafemme (ibrexafungerp tablets) from the market and putting a temporary hold on the drug’s clinical trials until it knows more details.
The advance of antifungals – a class long needful of new therapies – continued with Scynexis Inc.’s potential $593 million exclusive license agreement with GSK plc for Brexafemme (ibrexafungerp), first cleared by the U.S. FDA in June 2021 and indicated for vulvovaginal candidiasis (VVC) as well as for reduction of recurrent VVC.
Following a priority review, Scynexis Inc.'s oral antifungal, Brexafemme (ibrexafungerp), has won FDA approval for the treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. The one-day oral treatment, which kills a broad range of Candida species, including azole-resistant strains, represents the first approved drug in a new antifungal class in more than 20 years as well as being Scynexis’ first commercial product.
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in exchange for a $10 million up-front payment and as much as $112 million in milestones.
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Under the terms, Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in the region in exchange for a $10 million up- front payment and as much as $112 million in development and commercial milestones, plus low double-digit royalties on net product sales.
