The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...
Biogen Inc.’s BIIB Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal ...
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Biogen Inc.'s stock rose 1% Thursday, after Europe's pharmaceutical regulator issued a positive opinion on the Alzheimer's disease drug that the company developed with Japanese partner Eisai - ...
"After re-examining its initial opinion, the EMA... has recommended granting marketing authorisation to Leqembi (lecanemab) ...
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 ...
The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.
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 ...
"Amyloid-lowering treatments represent an important advance in the treatment of Alzheimer's disease but they are associated ...