Quviviq can be used on a long-term basis, addressing a key limitation of existing therapies
The Committee for Medicinal Products for Human Use (CHMP) has recommended Quviviq (daridorexant) as the first dual orexin receptor antagonist in the EU for the treatment of adult patients with insomnia.
The positive opinion is supported by pivotal phase 3 data, recently published in The Lancet Neurology. The results showcased that daridorexant improved nighttime symptoms and daytime functioning in adults with insomnia disorder at months one and three, compared to the placebo. The treatment also had a favourable safety profile.
Insomnia disorder is characterised by difficulty in falling and/or staying asleep, which can cause distress and impairment in significant areas of functioning. In order to be eligible for Quviviq, this impact on sleep quantity or quality should be present for at least three nights per week, last for at least three months and occur despite an adequate opportunity to sleep.
If approved, Quviviq would not only be the first dual orexin receptor antagonist made available in Europe, but also the first insomnia medicine to improve daytime functioning. In addition, with periodic reassessment of the need for therapy, Quviviq can be used for long-term treatment, addressing a key limitation of existing therapies.
Reflecting on this important CHMP approval, Jean-Paul Clozel, managing director and CEO of Idorsia, explained: “The recommendation from the CHMP is an important milestone for Idorsia and a significant step towards delivering a new treatment option for European patients with insomnia disorder.”
Clozel added: “This is represented in the unique indication adopted by the CHMP, for patients who have a considerable impact on daytime functioning, and for those who have been experiencing difficulty sleeping for an extended period. I am very proud that Idorsia will be the company to effect real change across Europe by bringing this innovation to patients.”