EISAI CO.LTD USP.ADR/1/4 Aktie

TOKYO and CAMBRIDGE, Mass., Nov. 14, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease (Early Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology.1 Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with European Medicines Agency regulatory process, the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion.2» Mehr auf prnewswire.com

The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with early Alzheimer's disease, months after the agency first rejected the treatment.» Mehr auf reuters.com

Leqembi has just started its commercial journey, and in order to achieve an appropriate or even discounted multiple, relatively modest penetration of the drug in the US would be needed. Lenvima is also continuing with solid growth, seeming to be on path to hit the forecast targets in 2025. The EMA decision to turn down Leqembi for now was disappointing, but it's already been approved in Japan, US, China and the UK.» Mehr auf seekingalpha.com