Medscape12h
Leqembi Okayed for Subset of Early Alzheimer’s Patients
The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...
Zacks.com on MSN15h
Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
Biogen Inc.’s BIIB Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal ...
The Pharma Letter12h
EMA/CHMP November recommendations include Leqembi U-turn
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November ...
ALZFORUM1d
Leqembi: Side Effects No Worse in Clinical Use Than They Were in Trial
An estimated 4,500 prescriptions have been filled in 2024 so far, Iwatsubo said. About 80 percent of patients have mild cognitive impairment, the rest have mild dementia. Most are in their 70s, and ...
GlobalData on MSN1d
EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
1. About lecanemab (generic name, brand name: Leqembi®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal ...
CHMP issues positive recommendation for approval of lecanemab in the EU
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued ...
GlobalData on MSN7d
Eisai lowers Leqembi revenue forecast after rocky entry to market
Leqembi is approved for Alzheimer’s patients in multiple territories, but questions remain over its cost-effectiveness.