- \n
- \nDiscovered by Takeda in Japan, ORZEYFUL has the Potential to Redefine Care Beyond Individual Symptom Management for Adults Living with Narcolepsy Type 1 (NT1)<\/p>\n<\/li>\n
- \nLandmark Phase 3 Studies Demonstrated Significant and Meaningful Improvements Across the Full Range of NT1 Symptoms Evaluated in Clinical Trials Compared to Placebo<\/p>\n<\/li>\n
- \nMilestone Marks Third Major Regulatory Approval Secured for ORZEYFUL Around the World<\/p>\n<\/li>\n<\/ul>\n
\n\u00a0<\/p>\n
OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–
\nTakeda (TOKYO:4502\/NYSE:TAK<\/a>) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. ORZEYFUL is a first-in-class oral orexin receptor 2 (OX2R) agonist and the only medicine indicated in Japan to treat the disease holistically rather than individual symptoms. The discovery of this new class of medicine originated in Takeda’s laboratories in Japan. Takeda is proceeding with launch preparations and expects to make ORZEYFUL available as quickly as possible.<\/p>\n\n\u201cOur discovery of the first orexin agonist is a successful representation of Japan-originated science that will directly impact people around the world living with narcolepsy type 1,\u201d said Julie Kim, president and chief executive officer of Takeda. \u201cWith the potential to redefine narcolepsy type 1 care, ORZEYFUL is the first validation of our broader orexin strategy, demonstrating how scientific innovation can create new possibilities for patients and drive future growth for Takeda\u201d<\/p>\n
\nNT1 is a chronic, rare neurological disease driven by orexin deficiency. People experience a range of daytime and nighttime symptoms including excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, sleep paralysis, hallucinations and cognitive symptoms. The persistent, 24-nature of the disease can severely impact many aspects of a person\u2019s life, including work, education and social interactions. Despite the substantial disease impact, limited awareness and the complexity of symptoms can contribute to misdiagnoses and an average diagnostic delay of more than 10 years.<\/p>\n
\n\u201cNT1 is a condition that can have a significant impact on patients\u2019 lives around the clock. Historically, treatment has primarily focused on managing individual symptoms. In recent years, advances in our understanding of the underlying pathophysiology of narcolepsy have led to the development of new therapeutic approaches,\u201d said Yuichi Inoue, professor, Department of Somnology, Tokyo Medical University. \u201cI look forward to seeing a broader range of treatment options become available, helping physicians tailor treatment to the needs of each individual patient.\u201d<\/p>\n
\nThe approval is based on a comprehensive clinical program including the global Phase 3 FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies that showed oveporexton offers statistically significant improvements across the full range of NT1 symptoms assessed. These included improvements in excessive daytime sleepiness, cataplexy and other secondary measures evaluated in the studies. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common adverse events were trouble sleeping (insomnia), urinary urgency, urinary frequency and excessive saliva. Learn more about the Phase 3 data results here<\/a>.<\/p>\n
\n\u201cWe credit our scientists in Japan who worked tirelessly to successfully discover a way to target the underlying orexin deficiency associated with narcolepsy type 1, a scientific feat that had never been achieved before,\u201d said Asuka Miyabashira, president, Japan Pharma Business Unit at Takeda. \u201cIt\u2019s exciting for a biopharmaceutical company to discover, develop and commercialize an asset internally, and we are proud to have worked with our colleagues, healthcare providers and patient community to bring this new class of treatment to adults living with narcolepsy type 1 in Japan.\u201d<\/p>\n
\nThe MHLW approval marks the third approval of ORZEYFUL around the world. ORZEYFUL is also approved for the treatment of NT1 in China as well as the United States (U.S.) where the controlled substance classification for ORZEYFUL is currently under review by the U.S. Drug Enforcement Administration (DEA).<\/p>\n
About ORZEYFUL (Oveporexton)<\/b><\/p>\n
\nORZEYFUL (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), to address a range of daytime and nighttime symptoms as evaluated in clinical studies and consistent with the approved label.<\/p>\n
About Takeda\u2019s Orexin Franchise<\/b><\/p>\n
\nTakeda 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\u2019s 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.<\/p>\n
About Takeda<\/b><\/p>\n
\nTakeda 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<\/a>.<\/p>\n
ORZEYFUL (oveporexton) Product Overview in Japan<\/b><\/p>\n
Product Name:
\n
<\/b>Orzeyful Tablet 0.5mg, 1mg, 2mg<\/p>\nGeneric Name:
\n
<\/b>Oveporexton<\/p>\nIndications and Effects:
\n
<\/b>Narcolepsy Type 1<\/p>\nDosage and administration:
\n
<\/b>The usual adult dosage of Oveporexton is 1mg administered orally two times daily. The first dose should be taken upon awakening and the second dose 3 to 5 hours later. The dose may be increased to 2 mg oral administration two times daily only when it is well tolerated and sufficient efficacy is not observed.<\/p>\nImportant Notice
\n
<\/b>For the purposes of this notice, \u201cpress release\u201d 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 (\u201cTakeda\u201d) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.<\/p>\n\nThe companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, \u201cTakeda\u201d is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words \u201cwe\u201d, \u201cus\u201d and \u201cour\u201d are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.<\/p>\n
Forward-Looking Statements
\n
<\/b>This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda\u2019s 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 \u201ctargets\u201d, \u201cplans\u201d, \u201cbelieves\u201d, \u201chopes\u201d, \u201ccontinues\u201d, \u201cexpects\u201d, \u201caims\u201d, \u201cintends\u201d, \u201censures\u201d, \u201cwill\u201d, \u201cmay\u201d, \u201cshould\u201d, \u201cwould\u201d, \u201ccould\u201d, \u201canticipates\u201d, \u201cestimates\u201d, \u201cprojects\u201d, \u201cforecasts\u201d, \u201coutlook\u201d 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\u2019s 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 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\u2019s most recent Annual Report on Form 20-F and Takeda\u2019s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda\u2019s website at: https:\/\/www.takeda.com\/investors\/sec-filings-and-security-reports\/<\/a> or at www.sec.gov<\/a>. 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\u2019s future results.<\/p>\nMedical Information<\/b><\/p>\n
\nThis 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.<\/p>\n
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View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260818063761\/en\/<\/a><\/span><\/p>\n
Investor Relations
\n<\/b>
Christopher O\u2019Reilly
\n<\/b>
takeda.ir.contact@takeda.com
\n<\/a><\/p>\nMedia Relations
\n<\/b>
Tsuyoshi Tada (Tokyo)
\n<\/b>
Toiawase_kouhou@takeda.co.jp
\n<\/a><\/p>\nRachel Wallace (Boston)
\n<\/b>
Media_relations@takeda.com<\/a><\/p>\nKEYWORDS:<\/b> Massachusetts United States Japan North America Asia Pacific<\/p>\n
INDUSTRY KEYWORDS:<\/b> Biotechnology FDA Health Pharmaceutical Clinical Trials<\/p>\n
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