CHMP recommends approval of Quviviq for insomnia.- Idorsia Pharmaceuticals
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Quviviq (daridorexant), from Idorsia Pharmaceuticals, intended for the treatment of insomnia. Quviviq will be available as 25 mg and 50 mg film-coated tablets.
The active substance daridorexant works as dual orexin receptor antagonist. The benefits of Quviviq are its ability to increase sleep induction, improve sleep maintenance and improve symptoms of daytime functioning. The most common side effects are headache and somnolence. The full indication is: Quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.
The positive CHMP opinion is supported by robust pivotal Phase III data, recently published in The Lancet Neurology, which demonstrated that daridorexant improved nighttime symptoms and daytime functioning in adults with insomnia disorder at months one and three compared to placebo, with a favorable safety profile. The efficacy and safety of Quviviq are further supported by a long-term follow-up extension study, which together with the pivotal trials, provides clinical data for up to 12 months of continuous treatment.
See-"Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase III trials"; The Lancet Neurology Vol. 21,No. 2p125–139 Published: February, 2022- Emmanuel Mignot, David Mayleben, Ingo Fietze, Damien Leger, Gary Zammit, Claudio L A Bassetti and others.
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