Today, the FDA granted traditional approved to lecanemab (branded as Leqembi), a monoclonal antibody from Eisai and Biogen for adult patients with Alzheimer’s disease. The agency made the decision on the basis of a confirmatory trial that showed its clinical benefit. The drug, which reduces the formation of amyloid plaques in the brain, is the…
CMS continues to restrict coverage of amyloid-targeting antibodies for Alzheimer’s
CMS has denied the Alzheimer’s Association’s request asking for broader reimbursement support for FDA-approved monoclonal antibodies targeting amyloid. In April 2022, CMS decided to limit coverage of such antibodies for Alzheimer’s to clinical trial volunteers. At that time, aducanumab from Biogen (Nasdaq: BIIB) and Eisai (TYO:4523) was the only FDA-approved antibody for the neurodegenerative condition. CMS…
Eisai prepares to share more findings for Alzheimer’s antibody lecanemab
Tokyo-headquartered Eisai Co. is preparing to share efficacy, safety and biomarker findings from its Phase 3 confirmatory clinical study of the amyloid beta-protein inhibitor lecanemab. The company will present full results from the Phase 3 confirmatory Clarity AD study of lecanemab in patients with early Alzheimer’s disease in a session at the Clinical Trials on…
Eisai amends Aduhelm collaboration with Biogen
Aduhelm (aducanuamab) co-developer Eisai Co. (TYO:4523) has agreed to modify its economic partnership agreement with Biogen (Nasdaq:BIIB). Starting January 1, 2023, Eisai will receive a tiered royalty on net sales of the Alzheimer’s disease therapy Aduhelm (aducanumab) rather than share profits or losses of the drug. Eisai would receive between 2% and 8% of annual sales…