Eisai
Pharmaceutical company focused on dementia and oncology
Medical Director - Medical Affairs, Alzheimer's Disease
+ Annual Incentive Plan + Long Term Incentive Plan
Remote within the United States.
About the job
- Advanced degree in sciences (Ph,D, PharmD or MD) or related field with 8+ years experience in the pharma/biotech industry.
- Practical knowledge of FDA regulations/ICH guidelines regarding clinical studies in relevant therapeutic area.
- Past leadership experience with management responsibilities (budgets, resources, vendors etc.) for cross-functional teams at a country/ large-region level.
- Oversee the planning and execution of real-world evidence and data generation activities
- Contribute to the Medical Affairs Plan and provide ongoing training and mentoring to associate directors
- Contribute to the development of medical strategy for major products and/or indications and provide critical medical input into the lifecycle management strategies in responsible therapeutic areas.
- Plan and implement real-world studies for assigned products.
- Serve as a medical leader and subject matter expert for relevant external (Health Care Professionals, strategic alliances etc.) and internal stakeholders.
- Serve as a medical expert to provide direction for assigned products on key internal business processes including active participation in relevant medical review committees.
- Work with key internal stakeholders to support development and communication of medical plans for the therapeutic area and track progress for reporting.
- Seek all relevant approvals of medical and scientific content for assigned therapeutic areas.
- Incorporate insights from scientific trends and treatment landscape by participating in external events and activities.
- Liaise with external stakeholders to solicit feedback and strengthen Eisai’s medical reputation in the disease state community.
- Direct and manage financial planning/forecasting and budget management, vendor management, timeline development & tracking, and assess resource needs for respective program(s) within scope of work.
- Manage talent within own area in terms of goal setting, performance management, development, and engagement.
- Preferred experience in the therapeutic area including in an in-house Medical Affairs role in a strategic decision-making capacity.
- Substantial experience across areas of Medical Affairs' functions in the therapeutic area is preferred.
About the company
Eisai is a Japanese research-based pharmaceutical company that discovers, develops, and markets prescription medicines under its "human health care (hhc)" concept. Its portfolio concentrates on neurology and oncology, including LEQEMBI (lecanemab), an anti-amyloid treatment for Alzheimer's disease now offered in intravenous and subcutaneous forms; lemborexant for insomnia; and the anticancer agent Halaven, developed through worldwide R&D and open-innovation partnerships. The company also runs a global health program that supplies medicines to more than 30 countries, having distributed billions of tablets to help eliminate neglected tropical diseases such as lymphatic filariasis. What sets Eisai apart is this hhc concept, which frames access and affordability—not only innovation—as central to its mission. The goal is to empower people to realize their fullest life by advancing treatments for conditions such as dementia and cancer.
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Total Funding
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Headquarters
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Founded
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Simplify's Take
What believers are saying
- Japan approved LEQEMBI Pen on September 16, 2026, expanding home treatment options.
- U.S. LEQEMBI IQLIK launched August 24, 2026, strengthening initiation and maintenance access.
- First-quarter fiscal 2026 global LEQEMBI sales reached ¥293 billion, up from ¥231 billion year over year.
What critics are saying
- Lenvima lost compound exclusivity in April 2026, exposing Eisai to generic pressure.
- Shilpa’s Lenvima appeal targets February 2036 protection; reversal accelerates oncology revenue erosion.
- LEQEMBI depends on payer coverage and ARIA monitoring; safety backlash or reimbursement cuts slow adoption.
What makes Eisai unique
- LEQEMBI IQLIK and LEQEMBI Pen give Eisai first-at-home anti-amyloid dosing in the U.S. and Japan.
- Eisai controls lecanemab development globally and holds final decision-making authority with Biogen.
- DAYVIGO and Nurtec co-promotion extend Eisai beyond Alzheimer’s into neurology and sleep medicines.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Flexible Work Hours
Remote Work Options
Paid Vacation
Paid Holidays
401(k) Retirement Plan
401(k) Company Match
Wellness Program
Mental Health Support
Conference Attendance Budget
Professional Development Budget
Stock Options
Company Equity
Family Planning Benefits
Fertility Treatment Support
Adoption Assistance
Childcare Support
Tuition Reimbursement
Professional Certification Support
Mentorship Program
Remote Work Options
Home Office Stipend
Phone/Internet Stipend
Company News
LEQEMBI(R) Pen (subcutaneous formulation of LEQEMBI(R) approved in Japan for the treatment of early Alzheimer's Disease. The first and only anti-amyloid treatment in Japan that enable at-home administration for Alzheimer's Disease, a progressive disease. TOKYO and CAMBRIDGE, Mass., Sept. 16, 2026 (GLOBE NEWSWIRE) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that "LEQEMBI(R) Pen", the subcutaneous (SC) formulation of the anti-amyloid beta (Aβ) protofibril antibody "LEQEMBI(R)" (brand name, generic name: lecanemab) has been approved in Japan as a new route of administration. LEQEMBI Pen is an autoinjector formulation that enables administration by a care partner or patient self-administration, with two pens (totaling 500 mg) administered once weekly. With this approval, LEQEMBI treatment now offers a new option of once-weekly SC administration at home*, in addition to intravenous (IV) administration every two weeks in a hospital setting. LEQEMBI Pen may reduce the time required for anti-amyloid therapy administration compared with IV infusions (approximate injection time of 15 seconds per injection). In addition, at-home administration may reduce the burden of clinic visits for patients and their care partners and provide greater flexibility in treatment, allowing patients to make treatment choices that better fit their lifestyles, including fewer constraints on going out and traveling. The improved convenience and flexibility of treatment with LEQEMBI is expected to lower barriers to initiating and continuing treatment with LEQEMBI. Furthermore, LEQEMBI Pen also has the potential to reduce healthcare resources associated with IV dosing, such as nurse monitoring, as well as maintaining infusion capacity. These features are expected to contribute to further streamlining the overall Alzheimer's disease (AD) treatment pathway. For amyloid-related imaging abnormalities (ARIA) monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation. AD is a progressive, relentless disease with Aβ and tau as hallmarks that is caused by a continuous underlying neurotoxic process driven by protofibrils that begins before amyloid plaque accumulation and continues after plaque removal.[1,2,] [3] Only LEQEMBI fights AD in two ways - targeting both protofibrils and amyloid plaque. This marks the third country globally to approve LEQEMBI SC formulation. This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of LEQEMBI in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia (collectively referred to as early AD), as well as multiple SC administration sub-studies in its subsequent long-term extension study (LTE). Once-weekly administration of SC formulation 500 mg demonstrated similar exposure to IV administration once every two weeks and supported the expectation that the SC formulation provides efficacy comparable to that of the IV formulation. The overall safety profile of SC administration was generally similar to that of IV administration, while systemic injection/infusion-related reactions were observed less frequently with SC administration (1.4%)** than with IV administration. Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. * At-home, self-administration using LEQEMBI Pen will be possible after it is listed in the injectable drug list designated by the Minister of Health, Labour and Welfare that health insurance doctor can administer (or prescribe), following deliberation and approval by the Central Social Insurance Medical Council, in principle within 60 days after approval. In addition, the following points are stipulated to be observed when self-administering. * When initiating administration, treatment must be administered by a physician or under the direct supervision of a physician at a medical facility. * With regard to the applicability of self-administration, the appropriateness thereof shall be carefully considered, and only after providing thorough education and training, and confirming that the patient or family member/caregiver understands the risks associated with administration of this drug and how to respond to them, and that the patient or family member/caregiver is able to reliably administer it themselves, shall self-administration be implemented under the management and guidance of a physician. ** Incidence in participants newly initiated on lecanemab treatment via SC administration, based on clinical data obtained from once-weekly subcutaneous administration of lecanemab 720 mg using vial formulations. | Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department +44 (0) 7760 619251 [email protected] Eisai Inc. (U.S.) Libby Holman +1-201-753-1945 [email protected] | Biogen Inc. Madeleine Shin +1-781-464-3260 [email protected] | | INVESTOR CONTACTS | / | | Eisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 | Biogen Inc. Tim Power + 1-781-464-2442 [email protected] | | / | / | Notes to Editors References * Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z * Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. * Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503. 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Leqembi Iqlik(R) for initiation treatment launched in the US. Aug 24, 2026, 08:39 ET STOCKHOLM, Aug. 24, 2026 /PRNewswire/ - BioArctic AB's (publ) (NASDAQ STOCKHOLM: BIOA B) partner Eisai today announced that lecanemab-irmb subcutaneous injection (US brand name: Leqembi Iqlik(R), which was approved by the FDA on July 13, now is available in the US for initiation therapy for early Alzheimer's disease[1]. Leqembi Iqlik is the first-of-its-kind anti-amyloid treatment that offers at-home dosing for initiation and maintenance (approved in the US). Leqembi Iqlik is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) infusion from the start of treatment. For initiation, the approved regimen is 500 mg once weekly, delivered as two 250 mg injections, each administered in approximately 15 seconds. Expanding convenience and flexibility in Alzheimer's care The availability of Leqembi Iqlik for both initiation and maintenance therapy in the US offers patients and carers greater convenience and flexibility throughout the treatment journey. At-home administration reduces the need for IV infusions and clinic visits, making treatment easier to integrate into daily life. Leqembi Iqlik may also help reduce healthcare resource utilization associated with IV administration. As with intravenous treatment, MRI monitoring for ARIA is required before treatment initiation and at specified time points thereafter. The information was released for public disclosure, through the agency of the contact person below, on August 24, 2026, at 2:05 pm CEST. For further information, please contact: Oskar Bosson, Chief Investor Relations & Communications Officer E-mail: [email protected] Telephone: +46 704 107 180 Jenny Ljunggren, External Communications and Investor Relations Manager E-mail: [email protected] Telephone: +46 76 013 86 08 About Leqembi(R)(lecanemab) Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Leqembi is approved in 53 countries and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 8 countries, including the United Kingdom, China, the US and Japan, and applications have been filed in 12 countries and regions. In the US, Leqembi Iqlik(R) is approved for subcutaneous dosing with an autoinjector as a starting dose and maintenance treatment of early Alzheimer's disease. In November 2025, a new drug application for subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, Leqembi was included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, the Biologics License Application for subcutaneous formulation of Leqembi was accepted in China and in February, the application was designated for priority review. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. About the collaboration between BioArctic and Eisai Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody lecanemab back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with sales milestones as well as royalties on global sales. About BioArctic AB BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi(R)(lecanemab) - the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter(TM) technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com. [[1]] Mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, is collectively referred to as early Alzheimer's disease. The following files are available for download: | https://mb.cision.com/Main/9978/4387047/4230386.pdf | Leqembi Iqlik(R) for initiation treatment launched in the US |. SOURCE BioArctic
Eurofarma announces strategic alliance with Eisai for the commercialization of DAYVIGO(R) in Brazil. Innovative medicine with a novel mechanism of action to enter the Brazilian market this year marking a new era in insomnia treatment Published in: August 17, 2026 and updated in: August 18, 2026 * To share Listen to the text São Paulo, August 17th de 2026 - Eurofarma and Eisai Laboratórios Ltda. ("Eisai") today announced a strategic alliance for the commercialization of DAYVIGO(R)(lemborexant), an innovative medicine indicated for the treatment of insomnia in adults and the first dual orexin receptor antagonist (DORA) approved in Brazil. The medicine has demonstrated consistent efficacy in sleep onset and maintenance across objective and patient-reported measures, with robust evidence of promoting a transition to sleep that more closely resembles the natural sleep pattern, with no evidence of risk of dependence.[1-3] Under the terms of the agreement, Eurofarma will be responsible for the commercialization, promotion, and distribution of DAYVIGO(R) throughout the country. Eisai will remain responsible for the product's marketing authorization and defining the brand's overall strategy in Brazil. The collaboration combines Eisai's global expertise in sleep medicine and central nervous system disorders with Eurofarma's extensive commercial reach, strong local market presence, and expertise in the central nervous system area, helping expand access to innovative treatment options for people living with insomnia. Insomnia is characterized by difficulty falling asleep, staying asleep, or both despite an adequate opportunity to sleep. When it occurs at least three times per week for a minimum period of one months, it may lead to fatigue, difficulty concentrating, and irritability[4,5]. The prevalence of insomnia disorder among adults in Brazil is estimated at approximately 15%[6], representing around 24 million adults living with the condition. Currently, the most commonly prescribed medications for insomnia in the country act directly by inducing drowsiness, and there is growing demand for new therapeutic options. "At Eurofarma, we continuously seek to identify and provide innovations capable of transforming people's lives. This partnership reinforces our strategy of connecting patients with differentiated, high-impact therapies, helping to raise the standard of care in areas with significant unmet medical needs", said João Siffert, Vice President of Innovation, Eurofarma. "This collaboration represents more than a commercial agreement; it reflects a shared commitment to addressing unmet medical needs in Brazil. By combining Eisai's scientific leadership in neuroscience with Eurofarma's extensive market expertise, we are expanding access to innovative therapies for people living with insomnia. Together, we are creating value for patients, healthcare professionals, and society", said Priscila Cavalcante, Commercial Director at Eisai. About DAYVIGO(R)(Lemborexant) DAYVIGO(R), an orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule and has been approved by the Brazilian Health Regulatory Agency (Anvisa) for the treatment of insomnia in adults characterized by difficulty initiating and/or maintaining sleep. It is a small molecule that inhibits orexin neurotransmission by competitively binding to both orexin receptor subtypes (orexin receptor 1 and orexin receptor 2)[8]. Its rapid association with and dissociation from orexin receptors may help improve both sleep onset and sleep maintenance[9]. The product has already been approved for the treatment of insomnia in more than 28 countries, including Japan, the United States, Canada, Australia, and several countries across Asia[10]. In randomized studies using both objective and subjective assessments, individuals treated with lemborexant demonstrated improvements in sleep parameters compared with placebo, including reduced sleep onset latency, increased sleep duration, and improved sleep efficiency. Efficacy and tolerability have also been shown to be maintained over 12 months of treatment. Furthermore, no evidence of rebound insomnia or withdrawal symptoms was observed following treatment discontinuation[3,6,11,12]. Studies conducted in both adults and older adults have also shown that lemborexant is not associated with clinically relevant residual morning effects, such as impaired postural stability upon awakening or reduced driving performance the next morning. Additionally, the medicine did not impair the ability to awaken in response to auditory stimuli[11-13]. The arrival of DAYVIGO(R) in the Brazilian market symbolizes a paradigm shift in a therapeutic area that has remained relatively stable for decades, representing one of the most significant recent innovations in sleep medicine. Referências 1. DRAGER, Luciano Ferreira et al. Consenso de diagnóstico e tratamento da insônia em adultos 2023. São Paulo: Segmento Farma Editores, 2023. Available at: Brazilian Insomnia Consensus. Accessed: January 20, 2026. 2. Kärppä M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. 3. Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Network Open. 2019 Dec 2;2(12):e1918254. 4. Ferrie JE, et al. Sleep epidemiology: a rapidly growing field. International Journal of Epidemiology. 2011;40(6):1431-1437. 5. Roth T. Insomnia: definition, prevalence, etiology and consequences. Journal of Clinical Sleep Medicine. 2007;3(5 Suppl):S7-S10. 6. Castro LS, Poyares D, et al. Objective prevalence of insomnia in the São Paulo, Brazil epidemiologic sleep study. Annals of Neurology. 2013;74(4):537-546. 7. Internal estimate. 8. Muehlan C, et al. The orexin story and orexin receptor antagonists for the treatment of insomnia. Journal of Sleep Research. 2023 Dec;32(6):e13902. 9. Beuckmann CT, et al. In Vitro and In Silico Characterization of Lemborexant (E2006), a Novel Dual Orexin Receptor Antagonist. Journal of Pharmacology and Experimental Therapeutics. 2017 Aug;362(2):287-295. 10. Eisai Global. 2025. Eisai Launches In-House Developed Anti-Insomnia Drug DAYVIGO(R)(Lemborexant) in China. Available at: Eisai News Release. Last accessed: July 2026. 11. Murphy P, Kumar D, Zammit G, Rosenberg R, Moline M. Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening. Journal of Clinical Sleep Medicine. 2020 May 15;16(5):765-773. 12. Gotfried MH, Auerbach SH, Dang-Vu TT, Mishima K, Kumar D, Moline M, Malhotra M. Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. Drugs & Aging. 2024 Sep;41(9):741-752. 13. Vermeeren A, Jongen S, Murphy P, Moline M, Filippov G, Pinner K, Perdomo C, Landry I, Majid O, Van Oers ACM, Van Leeuwen CJ, Ramaekers JG, Vuurman EFPM. On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. Sleep. 2019 Apr 1;42(4):zsy260. Erratum in: Sleep. 2020 Jul 13;43(7):zsaa068. About Eurofarma Founded in 1972, Eurofarma operates in the healthcare sector through the production and commercialization of products and services aimed at improving people's quality of life. Focused on generating shared value, the company operates across the main pharmaceutical segments, including prescription medicines, generics, hospital products, oncology, OTC medicines, personal care, and animal health, in addition to providing third-party manufacturing services. With broad therapeutic coverage, its portfolio includes more than 4,000 SKUs, serving virtually all medical specialties. The leader in prescription medicines in Brazil and the second-largest player in generics in the country, Eurofarma is present in 24 countries, with full coverage across Latin America and regional leadership in the retail market. The company also maintains operations in the United States and Africa, employs more than 13,000 people, and operated 10 manufacturing plants, producing 630 million units in 2025. In the same year, Eurofarma invested more than BRL 700 million in innovation projects and achieved net revenue exceeding BRL 12 billion. About Eisai Laboratórios Ltda. Founded in 2011 and headquartered in São Paulo, Eisai Laboratórios Ltda. is the Brazilian subsidiary of Eisai Co., Ltd., a global pharmaceutical company founded in Japan in 1941. The company is dedicated to improving the lives of patients and their families in Brazil by delivering innovative medicines that address significant unmet medical needs. Eisai's corporate concept is to give first thought to patients and people in the daily living domain, known as its human health care (hhc) concept. Guided by this philosophy, Eisai strives to create and deliver innovative medicines that address unmet medical needs, particularly in the strategic areas of Neurology and Oncology. Through its global network of research and development facilities, manufacturing sites and marketing subsidiaries, Eisai is committed to increasing the benefits that healthcare provides, relieving anxiety over health, and reducing health disparities around the world. Media Contact Eurofarma G&A Relações Públicas Iza França - 11 97644-4496 - [email protected] Guilherme Gaspar - 11 98285-6000 - [email protected] Murillo Israel - [email protected]
WashU Medicine honors CEO Haruo Naito and Eisai for longstanding contributions to Alzheimer's disease research and healthcare. August 18, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, "Eisai") announced today that Washington University School of Medicine in St. Louis ("WashU Medicine") held a ceremony unveiling a plaque honoring the longstanding contributions and achievements of CEO Haruo Naito and Eisai in healthcare, including in the field of Alzheimer's disease (AD). The plaque, commemorating these achievements, will be permanently displayed on a wall in the lobby of the Jeffrey T. Fort Neuroscience Research Building (NRB). CEO Haruo Naito and Eisai were recognized for their long-term and significant contributions to WashU Medicine and the Knight Family Dominantly Inherited Alzheimer Network-Trials Unit (DIAN-TU), as well as for the profound impact CEO Naito's leadership and vision have had on patients, families and researchers around the world. Eisai and WashU Medicine have been collaborating in research on neurodegenerative diseases, including dementia and Parkinson's disease. In particular, in the AD field, the Phase II/III Tau NexGen Study conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by the University's School of Medicine, is exploring the safety, tolerability, biomarkers and cognitive efficacy of Eisai's anti-MTBR (microtubule binding region) tau antibody etalanetug (E2814) for the treatment of dominantly inherited Alzheimer's disease (DIAD). In this study, the anti-amyloid beta (Aβ) protofibril antibody lecanemab was selected as the backbone anti-amyloid therapy. The collaboration between WashU Medicine neuroscience researchers and Eisai reinforces a shared mission of advancing human healthcare, which accelerates turning discoveries from medical research into solutions for patients, improving care for families today while working toward a future free of neurodegenerative disease. Media contacts: Public Relations Department, Eisai Co., Ltd.
FDA approves Takeda's first-in-class narcolepsy drug. Key summary: * FDA clears first drug to treat the underlying cause of narcolepsy type 1. * Takeda forecasts peak annual sales of up to $5bn for Orzeyful. * Rivals including Alkermes, Eli Lilly and Eisai are racing to develop competing therapies. Takeda has secured FDA approval for the first drug to treat the underlying cause of narcolepsy type 1, with the company forecasting peak annual sales of between $2bn and $3bn as it seeks further regulatory approvals. Known as Orzeyful (oveporexton), the therapy is an orexin receptor 2 agonist that restores a brain signal missing in people with narcolepsy type 1. Unlike existing treatments, it targets the underlying cause of the disease rather than simply treating its symptoms. Narcolepsy is a chronic neurological disorder characterised by excessive daytime sleepiness, sudden muscle weakness known as cataplexy, sleep paralysis and vivid hallucinations. For now, Orzeyful is approved only for adults with narcolepsy type 1 in the US. Its safety and efficacy have not yet been established in people younger than 18 years in the country. Orzeyful's efficacy. The approval was backed by positive results from two pivotal clinical trials. In the FirstLight and RadiantLight studies, Orzeyful significantly improved patients' ability to stay awake compared with placebo. The therapy also reduced cataplexy, sleep paralysis, hallucinations and disrupted night-time sleep. The most common adverse events included insomnia, increased urinary frequency, urinary urgency and increased salivation. "The FDA approval of Orzeyful marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and how people feel on treatment," said Julie Kim, President and Chief Executive Officer, Takeda. The company expects to launch Orzeyful in the US in November, subject to scheduling by the Drug Enforcement Administration. Further approvals. The FDA's decision follows Orzeyful's clearance in China last month for adults and adolescents aged 16 years and older. The therapy also remains under review in Japan, while Takeda plans to file for approval in Europe later this year. Although Takeda is first to market, competition is already building. Irish biopharmaceutical company Alkermes is progressing alixorexton through phase 3 trials, while Eli Lilly's cleminorexton and Eisai's ledasorexton are both in phase 2 development. Brain health company Lundbeck is also developing Lu AH69593, which is in phase 1b trials. Press play to listen to this content