°®¶¹´«Ã½

• For Print
• April 14, 2021

°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company will conduct presentations, including the latest data of the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (development code: BAN2401), its dual orexin receptor antagonist lemborexant (product name: Dayvigo^®) and its antiepileptic drug perampanel (product name: Fycompa^®), at the Virtual American Academy of Neurology (AAN 2021) Annual Meeting from April 17 to 22, 2021.

As major presentations, an oral presentation regarding lecanemab will be given on the preliminary analysis for results of changes in brain-Aβ levels and amyloid-related imaging abnormalities-edema (ARIA-E) as observed in subjects of the ongoing open-label extension of the Phase II study (Study 201) for early Alzheimer’s disease (AD) patients. Poster presentations regarding lemborexant are also planned, including the results of a pilot study evaluating next-dose transition from zolpidem to lemborexant for insomnia treatment. Additionally, for perampanel, a global pooled analysis results from the real-world experiences including early adjunctive use or monotherapy will be presented at poster sessions.  

Eisai considers neurology a therapeutic area of focus. Eisai strives to create innovative products in therapeutic areas with high unmet medical needs as soon as possible, and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with the disease and their families.

AD/Dementia Oral Presentation:

AD/Dementia Poster Presentation:

Insomnia Poster Presentations:

Epilepsy Poster Presentations:

Biogen AD/Dementia Poster Presentation:

Poster presentations can be browsed at any time on the AAN website during the conference.

Media Inquiries:

Public Relations Department,

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+81-(0)3-3817-5120

<Notes to editors>

1. °®¶¹´«Ã½ the Joint Development Agreement between Eisai and Biogen for AD

Eisai and Biogen Inc. (Headquarters: Cambridge, Massachusetts, United States) are widely collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab (Development Code: BAN2401), an anti-Aβ protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen’s investigational anti-Aβ antibody for patients with AD, and the companies plan to pursue marketing authorizations for the two compounds worldwide. If approved, the companies will also co-promote the products in major markets, such as the United States, Europe and Japan.

2. °®¶¹´«Ã½ Lecanemab (development code: BAN2401)

Lecanemab is a humanized monoclonal antibody for AD that is the result of a strategic research alliance between Eisai and BioArctic AB (Headquarters: Sweden). Lecanemab selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (protofibril) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Study 201 demonstrated a statistically significant slowing of disease progression and decreasing of brain Aβ accumulation as the first late-stage large-scale clinical study for early AD, and successfully showed potential disease-modifying effects. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. Currently, an open-label extension study (OLE) of the Phase II study (Study 201) and a pivotal clinical Phase III study (Clarity AD) of lecanemab in early AD is underway. The clinical Phase III study (AHEAD 3-45) of lecanemab in preclinical AD is also underway. The National Institutes of Health, National Institute of Aging are providing funding for the AHEAD 3-45 (A45 Study and A3 Study). Eisai and Biogen Inc. have entered into a collaboration to develop and commercialize BAN2401.

3. °®¶¹´«Ã½ Lemborexant (product name: Dayvigo)

Lemborexant, an orexin receptor antagonist, is Eisai’s in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Faster on/off receptor kinetics of lemborexant to orexin receptor 2, which also suppresses non-REM sleep, may influence lemborexant’s potential to facilitate improvements in sleep onset and maintenance. In June 2020, lemborexant was launched under the product name DAYVIGO in the U.S. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; and in July 2020, it was launched under the product name DAYVIGO in Japan for the treatment of insomnia. Eisai has submitted new drug applications seeking approval of DAYVIGO in Canada, Australia and others.

4. °®¶¹´«Ã½ Perampanel (product name: Fycompa)

Perampanel is a first-in-class anti-epileptic agent (AED) discovered and developed by Eisai. With epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Perampanel is currently approved in more than 70 countries and territories, including Japan, the United States, China, and other countries in Europe and in Asia as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. In addition, perampanel has been approved in more than 70 countries, including the United States, Japan, in Europe and in Asia for treatment as an adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. In Japan and the United States, perampanel is approved for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. In Europe the approved age range is 4 years of age and older for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) and 7 years of age and older for the treatment as an adjunctive therapy for primary generalized tonic-clonic seizure. Perampanel is available in drug form to be taken once daily orally at bedtime. A tablet and fine granule formulation have been approved in Japan. An oral suspension formulation and tablet have been approved in the United States and Europe. Eisai is conducting development of an injection formulation.

5. °®¶¹´«Ã½ Lorcaserin

By selectively activating serotonin 2C receptors in the brain, through the activation GABAergic inhibitory interneuron, expected to suppress seizure of Dravet syndrome by increasing synaptic suppression from GABAergic. Although approval for the obesity indication has been voluntarily withdrawn, due to the request from Dravet syndrome patient groups, the extended access program has been continued in the United States, and the Phase III study is underway for this indication. The FDA has designated it as an orphan drug for Dravet syndrome.

6. °®¶¹´«Ã½ Aducanumab (development code: BIIB037)

Aducanumab is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. Based on clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients’ ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s disease.

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.

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