Takeda’s ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 1

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Postmedia has not reviewed the content. by Business Wire Takeda's ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 1Author of the article:− ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) − Discovered by Takeda scientists in Japan, ORZEYFUL is the lead medicine in Takeda’s orexin franchise, with multiple programs for sleep-wake disorders and conditions where orexin biology plays a role − ORZEYFUL set to launch next month in the U.S., following completion of DEA scheduling; Health Authority submissions underway worldwideOSAKA, Japan & CAMBRIDGE, Mass. — Takeda ( TSE:4502/NYSE:TAK) announced today that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. ORZEYFUL is a first-in-class orexin receptor 2 (OX2R) agonist, in tablet form, designed to treat the underlying orexin deficiency associated with NT1.THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an AccountThis advertisement has not loaded yet, but your article continues below.“We’re excited at the potential to fundamentally change how NT1 is managed across Japan and China,” said Giles Platford, president, International, Takeda. “We’ve heard from patients how ORZEYFUL has improved their daily functioning and quality of life, enormously meaningful outcomes for a condition known to impact many aspects of a person’s life, including work, education and social interactions.”1,2,3,4,5 NT1 is a chronic, rare neurological disease driven by orexin deficiency. People experience a range of symptoms including excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, sleep paralysis, hallucinations and cognitive symptoms. Many patients experience challenges that may affect their quality of life and limit their independence. People with narcolepsy have approximately twice the rate of healthcare resource utilization compared with controls, including more frequent emergency department visits, hospitalizations, outpatient appointments and physician consultations.6,7,8 ORZEYFUL is the first therapy designed to restore orexin signaling and address the biological cause of NT1. This mechanism represents a potential paradigm shift from symptom management to a disease-targeted treatment. Landmark Phase 3 studies in people with NT1 demonstrated ORZEYFUL improved the full range of NT1 symptoms and quality of life compared with placebo9. Results showed consistent, clinically meaningful and statistically significant improvements with ORZEYFUL compared to placebo in wakefulness, sleepiness, cataplexy, disease severity and quality of life measures (p-values of <0.001) across doses over 12 weeks. These improvements were observed at the earliest assessed timepoint for each measure and were sustained throughout the duration of the studies. ORZEYFUL was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common side effects include insomnia, urinary urgency, urinary frequency and excessive saliva.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againAbout ORZEYFUL (Oveporexton)ORZEYFUL (oveporexton) is an oral orexin receptor 2 (OX2R) agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency associated with narcolepsy type 1 (NT1). By activating OX2Rs, ORZEYFUL promotes wakefulness and reduces abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy (sudden and temporary loss of muscle tone), and address a range of daytime and nighttime symptoms as evaluated in clinical studies and consistent with the approved label.This advertisement has not loaded yet, but your article continues below.About Takeda’s Orexin FranchiseTakeda is the leader in orexin science with a tailored portfolio of investigational orexin agonists in pre-clinical and clinical stages for multiple-sleep wake disorders and other indications where orexin plays a role including respiration, mood and metabolism. Oveporexton is the lead orexin receptor 2 (OX2R) agonist in Takeda’s orexin franchise and has been approved by regulatory bodies in China for the treatment of narcolepsy type 1(NT1) in adolescents aged 16 and older and adults as well as in the United States and Japan for adults with NT1. The company is also investigating other oral orexin agonists, including TAK-360 for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), as well as TAK-495.Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. 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These expressions are also used where no useful purpose is served by identifying the particular company or companies.Takeda Forward-Looking StatementsThis press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at https://www.sec.gov/. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.This advertisement has not loaded yet, but your article continues below.Takeda Medical InformationThis press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.Plazzi G, Dauvilliers Y, Pizza F, et al. Effect of the Oral Orexin Receptor 2 Agonist Oveporexton (TAK-861) on Functional Impacts of Narcolepsy Type 1: Results from Two Phase 3 Studies. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD.Pizza F, Dauvilliers Y, Del Rio Villegas R, et al. Oveporexton (TAK-861) Improves Cognitive Symptoms in Patients with Narcolepsy Type 1: Results from Two Randomized, Placebo-controlled Phase 3 Trials. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD.Barateau L, Gong Y, Dauvilliers Y, et al. Effects of Treatment with Oveporexton, an Orexin Receptor 2 Agonist, on Sleep in People with Narcolepsy Type 1: Phase 3 Results. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD.Maski K, Steinhart E, Williams D, et al. Listening to the patient voice in narcolepsy: diagnostic delay, disease burden, and treatment efficacy. J Clin Sleep Med. 2017;13(3):419-425.Flores NM, Villa KF, Black J, et al. The humanistic and economic burden of narcolepsy. J Clin Sleep Med. 2016;12(03):401-407.Thorpy MJ and Hiller G. The medical and economic burden of narcolepsy: implications for managed care. Am Health Drug Benefits. 2017;10(5):233-241.Jennum P, Ibsen R, Petersen ER, et al. Health, social, and economic consequences of narcolepsy: a controlled national study evaluating the societal effect on patients and their partners. Sleep Med. 2012;13(8):1086–93.Black J, Reaven NL, Funk SE, et al. The Burden of Narcolepsy Disease (BOND) study: health-care utilization and cost findings. Sleep Med. 2014 May;15(5):522–9.Dauvilliers Y, Mignot E, Antczak J, et al. Oveporexton for Narcolepsy Type 1: Results from Two Phase 3 Trials. New England Journal of Medicine 2026.View source version on businesswire.com: This advertisement has not loaded yet.Notice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. 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