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Eisai submits sBLA to USFDA for its key drug to treat early Alzheimer’s disease
Eisai planned to initiate a rolling BLA for lecanemab SC maintenance in the first quarter 2024, under lecanemab’s existing Fast Track and Breakthrough Therapy designations, the company stated.
CNN1mon
How much longer you might live without assistance on new Alzheimer’s drugs
Your doctor might suggest taking one of the newer medications such as lecanemab or donanemab, which have been shown in clinical trials to clear plaque-causing amyloid proteins from the brain that ...
pharmaphorum5d
Getting approval will only be the first challenge facing lecanemab
GlobalData is betting on approval of lecanemab and the lifting of reimbursement restrictions, with a prediction of $2.76 billion in sales of the drug in the top eight pharma markets (US, France ...
Nasdaq15d
The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
Following CHMP's reaffirmation, after having considered the additional information requested by the European Commission (EC), the EC will resume the decision-making process for lecanemab's ...
News Medical27d
Lecanemab and donanemab slow Alzheimer’s decline, but is the benefit worth the cost?
New research shows that lecanemab and donanemab can slow cognitive decline and extend patients' independence in daily activities. But with high costs and risks, are these treatments truly ...
Nasdaq15d
The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease
In January 2025, as part of its decision-making process, the EC asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in ...