Lecanemab s Regulatory Review for Early Alzheimer s Disease Receives Negative Opinion in the European Union
In a recent announcement, Eisai Co., Ltd. and Biogen Inc. revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rejected the Marketing Authorization Approval (MAA) for lecanemab, a humanized anti-soluble aggregated amyloid-beta (A?) monoclonal antibody, as a treatment for early Alzheimer''s disease (AD). This decision comes as an unfortunate setback in the search for effective therapies to address the devastating cognitive decline associated with AD. Biogen Inc., the key player behind lecanemab, has also experienced a decline in its asset returns. Let''s delve into the details. Lecanemab Faces Regulatory Hurdles: The CHMP''s negative opinion on lecanemab''s MAA for treating mild cognitive impairment due to AD and mild AD is a significant setback for both Eisai Co., Ltd. and Biogen Inc. Lecanemab showed promising potential in targeting and reducing aggregated amyloid-beta plaques, a hallmark of AD pathology. However, based on the available clinical data, the CHMP concluded that the currently presented evidence was insufficient to demonstrate the antibody''s effectiveness in treating early stages of the disease.
https://csimarket.com/news/lecanemab-s-regulatory-review-for-early-alzheimer-s-disease-receives-negative-opinion-in-the-european-union2024-07-26112428