Authors: Nicole DeFeudisAssociate Editor The FDA ushered in a new class of triterpenoid antifungals this week, giving Scynexis the OK for its oral ibrexafungerp — a non-azole treatment the company designed to dethrone Pfizer’s fluconazole in vaginal yeast infection. The decision came right on time for Scynexis’ June 1 PDUFA date, and was based on two Phase III trials in which about 50% and 63% of patients given the drug, respectively, saw all signs and symptoms of their yeast infections disappear by day 10. Just about 29% and 44% of patients on the placebo saw a clinical cure by Day 10, according to data presented at the American College of Obstetricians and Gynecologists in April. By Day 25, symptom resolution in the treatment arms increased to 60% and nearly 74%, Scynexis reported. “This first approval in the U.S. is a major step towards building the ibrexafungerp antifungal franchise as we intend to leverage an extended 10-year period of regulatory exclusivity and 14 years of patent protection,” CEO Marco Taglietti said in a statement. Though vaginal yeast infections — also known as vulvovaginal candidiasis (VVC)— affect three out of four women across their lifetimes, the condition
Most cases of catheter-related bloodstream infections (CRBSIs) involve colonization of micro-organisms on catheter surfaces where they eventually become embedded in a biofilm.