The EC’s decision on the insomnia treatment was supported by phase 3 trial results.
Idorsia has announced that the European Commission (EC) has granted marketing authorisation for Quviviq (daridorexant) for the treatment of adult patients with insomnia.
The approval marks Quviviq as Europe’s first dual orexin receptor antagonist – the drug blocks only the activation of orexin receptors, as opposed to inducing sleep through broad inhibition of brain activity.
Orexin is a small, protein-like molecule produced by the brain, called a neuropeptide. Orexin promotes wakefulness and, by targeting the molecule, Idorsia’s treatment improves sleep onset and maintenance, without next-morning residual effects.
Furthermore, Quviviq does not broadly inhibit brain activity to cause sleep, and so the drug decreases the wake drive without altering the proportion of sleep stages, improving daytime functioning.
Professor Damien Léger, Université Paris Cité, France, commented: “Sleep is an essential pillar for good physical and mental health to ensure optimal functioning throughout the day. Chronic insomnia disorder is persistent in many patients and has direct consequences, such as impaired daytime function, decreased workplace productivity, injuries and accidents, making insomnia not only a disease of the night but one that also markedly affects the day and a patient’s well-being.
“Quviviq, which can be used long-term, effectively improves sleep parameters and people’s ability to function better during the day, while avoiding major safety concerns, fulfilling the major medical requirements for insomnia management. This is great news for the millions of adults and elderly people across the EU living with chronic insomnia,” he added.
Phase 3 trial results were recently published in The Lancet Neurology and demonstrated that the recommended dose of Quviviq improved sleep onset, maintenance and self-reported total sleep time among adults with chronic insomnia disorder.
Insomnia is a common problem, estimated to affect 6-12% of the adult population in Europe. Poor quality of sleep can affect many aspects of daily life, including the ability to concentrate, professional life, mood, and energy levels and is associated with other significant health impacts.
