Insomnia treatment approved in Japan
Drug Discovery World
SEPTEMBER 27, 2024
Nxera Pharma Japan has received approval from the Ministry of Health, Labour and Welfare of Japan (MHLW) of its New Drug Application (NDA) for ACT-541468 (daridorexant or Quviviq) in 25 and 50mg doses for the treatment of adult patients with insomnia. 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.
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