Posted by Michael Wonder on 12 Aug 2021
FDA grants first of its kind indication for chronic sleep disorder treatment
12 August 2021 - The U.S. Food and Drug Administration today approved a new indication for Xywav for idiopathic hypersomnia in adults.
The effectiveness of Xywav was evaluated in a double blind, placebo controlled, randomised withdrawal study in 154 adult patients (ages 19 to 75 years) with idiopathic hypersomnia.
