Nxera Pharma Co., Ltd. Receives Approval for New Insomnia Treatment in Japan
Tokyo, Japan and Cambridge, UK, 24 September 2024
Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – announces that Nxera Pharma Japan Co., Ltd. (“NPJ”) has received approval from the Ministry of Health, Labour and Welfare of Japan (“MHLW”) of its New Drug Application (“NDA”) for QUVIVIQ™ (daridorexant; ACT-541468) 25 and 50 mg 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 3 trial. Plans to make QUVIVIQ available as soon as possible to insomnia patients in Japan are underway.
This milestone marks a significant advancement in the treatment options available for individuals suffering from insomnia in Japan. QUVIVIQ has shown promising results in clinical trials, demonstrating its potential to improve sleep quality and duration in patients with insomnia. The approval by the MHLW further solidifies the efficacy and safety profile of this new treatment, offering hope to those who have been struggling with sleep disorders.
Impact on Individuals
For individuals in Japan struggling with insomnia, the approval of QUVIVIQ represents a new opportunity for effective treatment. With its dual orexin receptor antagonist mechanism of action, QUVIVIQ offers a novel approach to improving sleep quality and addressing the underlying causes of insomnia. Patients may experience better sleep outcomes and improved overall well-being with the availability of this new medication.
Impact on the World
The approval of QUVIVIQ in Japan also has broader implications for the global healthcare community. As a new treatment option for insomnia, QUVIVIQ may pave the way for future advancements in sleep disorders research and pharmacotherapy. The success of this novel dual orexin receptor antagonist could inspire further innovation in the field of sleep medicine, leading to improved treatments and outcomes for individuals worldwide.
Conclusion
The approval of QUVIVIQ by the MHLW represents a significant milestone in the treatment of insomnia in Japan. With its innovative mechanism of action and promising clinical data, QUVIVIQ offers new hope for individuals struggling with sleep disorders. The impact of this approval extends beyond Japan, potentially shaping the future of sleep medicine on a global scale.
