Nxera Pharma’s Quviviq approved in Japan for insomnia

24 September 2024

Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma (TYO: 45650.

The approval of Quviviq, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data including from a dedicated Japanese Phase III trial. Plans to make Quviviq available as soon as possible to insomnia patients in Japan are underway, said Nxera, formerly known as Sosei Group or Sosei Heptares.

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