www.fdanews.com/articles/207665-european-commission-greenlights-idorsias-insomnia-drug-quviviq
European Commission Greenlights Idorsia’s Insomnia Drug Quviviq
May 4, 2022
The European Commission has granted marketing authorization for Idorsia’s Quviviq (daridorexant) for the treatment of adult patients with chronic insomnia disorder.
Quviviq, which was approved in the U.S. in January, operates by blocking the binding of wake-promoting neuropeptides orexins.
In a study with 1,854 participants, 50 mg of Quviviq led to significant improvements in sleep onset, sleep maintenance and self-reported total sleep time compared to placebo.