FDA approved AMAG Pharmaceuticals’ Vyleesi, expanded the indication of Symdeko for patients with CF
The US Food and Drug Administration (FDA) approved AMAG Pharmaceuticals Vyleesi (bremelanotide) for treatment of acquired generalized hypoactive sexual desire disorder (HSSD) in premenopausal women.
The approval was based on the 24-week double-blind, placebo-controlled trial. Women with acquired, generalized HSSD was considered. 25% of patients had an increase in the rage of 1.2 to 6.0 compared to 17% in patients on placebo. But it has no impact on sexual desire.
FDA has expanded Symdeko (a combination of tezacaftor and ivacaftor) for patients of the age of 6 years and older. The efficacy of Symdeko was approved based on Phase 3, double blind placebo-controlled trials. The approval was based on extrapolation to the patients of age 6 to 12 years. 70 patients of 6 to 12 years with cystic fibrosis were included in the study. They have safety similar to 12 years.