Release
2024/12/19
OSAKA, Japan, December 19, 2024 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") and Nxera Pharma Co., Ltd.（Head office: Tokyo, Chief Executive Officer: Christopher Cargill, hereafter ”Nxera Pharma”) announced that QUVIVIQ™ (daridorexant) 25 and 50 mg has been launched and is now available in Japan as a new treatment for adults with insomnia.
QUVIVIQ™ is an oral Dual Orexin Receptor Antagonist for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep.
Shionogi will be solely responsible for distribution and sales activities for QUVIVIQ™ in Japan under the commercial partnership agreement with Nxera Pharma announced on 1 October 2024. Nxera Pharma Japan Co., Ltd. (a wholly owned subsidiary of Nxera Pharma) is the approval holder and will be responsible in part for provision of drug product1,2.
For Nxera, reaching this important milestone highlights its ability to develop novel therapeutics for patients in Japan and reinforces its ambition to be a partner of choice for companies looking to develop and commercialize new therapeutics for the Japanese market.
As a new pillar, Shionogi is focusing on the 'QOL disease area,' which is less affected by trends. Starting with the launch of QUVIVIQTM, we are working to strengthen the 'QOL disease area' as a solid pillar
Together, Nxera and Shionogi are committed to deliver QUVIVIQ™ as quickly as possible as a product that has the potential to meet the needs of insomnia patients for a long time to come.
References
Product Information |
|
Product name |
QUVIVIQ™ 25 mg, 50 mg |
Non-proprietary name |
daridorexant |
Indication |
Insomnia |
Dosage regimen |
The usual adult dosage is 50 mg of daridorexant to be taken orally once daily immediately before bedtime. In addition, depending on the patient's condition, 25 mg can be administered once daily. |
Date of approval |
24 September 2024 |
Date of NHI price listing |
20 November 2024 |
Date of launch |
19 December 2024 |
Drug price |
JPY57.30 per 25 mg tablet JPY90.80 per 50 mg tablet |
Approval holder |
Nxera Pharma Japan Co., Ltd. |
Distributor |
Shionogi & Co., Ltd. |
About QUVIVIQTM
QUVIVIQ™ (daridorexant) is a dual orexin receptor antagonist, discovered by Idorsia Pharmaceuticals Ltd, that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. In October 2022, daridorexant achieved positive Phase 3 top-line results in Japanese patients with insomnia and Nxera Pharma Japan has obtained the manufacturing and marketing approval in Japan for QUVIVIQTM as a treatment for adult patients with insomnia, as of September 24, 2024*. Daridorexant is approved in the US, Europe and Canada, and marketed in these territories under the brand name QUVIVIQ™ by Idorsia Pharmaceuticals Ltd.
* Press release on September 24,2024 by Nxera Pharma
About Insomnia Disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep.
Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. According to a survey by Japan’s Ministry of Health, Labour and Welfare in 2018, about 20% of Japanese adults struggle to get enough rest from sleep.
Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.
The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy.
About Shionogi
Shionogi strives constantly to supply the best possible medicine (healthcare solutions) to protect the health and wellbeing of the patients we serve, and as a united group. We have identified Contributing to a Healthy and Prosperous Life as a material focus. We are committed to creating a society where everyone can lead a longer, more vibrant life, realizing their goals.
For more information, please visit https://www.shionogi.com/global/en/
About Nxera Pharma
Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. For more information, please visit www.nxera.life
For Further Information, Contact:
SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.htm
Nxera Pharma Website Inquiry Form: https://www.nxera.life/contact