ESALY - ESALY STOCK NEWS

Eisai announces the FDA approval of LEQEMBI (lecanemab-rimb), a new treatment option for early Alzheimer's disease. The medication aims to benefit patients, families, and healthcare providers, offering essential information through the U.S. Prescribing Information to guide usage and monitor potential side effects, particularly amyloid-related imaging abnormalities (ARIA). Patient safety remains a top priority, with continuous monitoring of adverse events. The company emphasizes collaboration with the FDA to ensure comprehensive safety updates.

Eisai Co., Ltd. and Biogen Inc. have initiated the submission of a Biologics License Application (BLA) for lecanemab to China's National Medical Products Administration (NMPA). This Category 1 drug aims to treat Alzheimer's disease and has shown positive results in clinical trials, including the Phase III Clarity AD study, which met its primary and key secondary endpoints. The submission package includes data from Phase II and III trials with significant efficacy outcomes. Eisai plans to seek additional approvals in Japan and Europe by March 31, 2023.

Eisai and Biogen announced the publication of results from the Phase 3 Clarity AD study of lecanemab, an investigational antibody aimed at treating early Alzheimer's disease with confirmed amyloid pathology. The results, published in the New England Journal of Medicine, reinforce Eisai's commitment to transparency in disclosing data on lecanemab. Eisai leads global development and regulatory submissions, targeting expedited delivery of lecanemab to patients. The FDA's decision on traditional approval is anticipated around January 6, 2023.

Eisai and Biogen announced the presentation of results from the global Phase 3 Clarity AD clinical study of lecanemab, an investigational antibody for early Alzheimer's disease, at the CTAD conference. The study involved 1,795 participants and demonstrated significant clinical benefits, including a 27% reduction in cognitive decline compared to placebo over 18 months. Key secondary endpoints, such as amyloid plaque reduction, also showed highly statistically significant results. While ARIA-related side effects were noted, they were largely mild to moderate, with no deaths attributed to lecanemab during the study.

Eisai Inc. has appointed Thomas D. Fagan Jr. as Vice President, U.S. Alzheimer's Disease Commercial, effective immediately. In his role, Fagan will shape the commercial launch strategy for the company’s Alzheimer's business and expand its team. He brings over 20 years of experience, specifically in Alzheimer’s disease, and will support the potential launch of a late-stage investigational therapy. Eisai focuses on human health care, aiming to enhance patient access to innovative therapies.

Eisai Co. Ltd announced it will present crucial research on lecanemab, an investigational anti-amyloid beta antibody for early Alzheimer's disease, at the Alzheimer's Association International Conference (AAIC) from July 31 to August 4, 2022. The company received FDA acceptance for lecanemab's Biologics License Application on July 5, 2022, with a priority review action date set for January 6, 2023. Highlights include presentations on the role of genotype in ARIA-E incidence and dosing studies. Eisai aims to improve racial and ethnic diversity in clinical trials while advancing its Alzheimer's research initiatives.

Eisai Co., Ltd. announced seven poster presentations at the SLEEP 2022 meeting, showcasing data on its orexin receptor antagonist, lemborexant (DAYVIGO^®CIV). Key findings include a subgroup analysis of the Phase III clinical study focused on older adults with insomnia. The presentations will occur from June 4-8, 2022, in Charlotte, NC. Eisai aims to address the significant impact of insomnia on daily functioning, with lemborexant approved in over 10 countries, including the U.S. and Japan.

Eisai and Biogen announced the completion of a rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab (BAN2401), an investigational treatment for mild cognitive impairment due to Alzheimer's disease. The submission is under the accelerated approval pathway, with a request for Priority Review. The Phase 3 Clarity AD trial, involving 1,795 patients, is expected to report results in Fall 2022 and will serve as confirmatory evidence for lecanemab's clinical benefits. The BLA is supported by extensive safety and efficacy data from earlier trials.

Geisinger and Eisai Inc. have announced a collaborative research initiative to evaluate an AI tool for detecting cognitive impairment that may indicate dementia, including Alzheimer's disease. The study will apply a novel algorithm called the Passive Digital Marker (PDM), developed by Purdue and Indiana University, on Geisinger’s de-identified patient data. With over 55 million people currently living with dementia, early detection is crucial for effective treatment. This collaboration aims to enhance diagnosis and improve patient outcomes, leveraging AI technology.