FiercePharma2d
CHMP again backs Leqembi amid flurry of approval recommendations
Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...
Biogen, Eisai: CHMP Reaffirms Backing of Leqembi Alzheimer's Drug
Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.
Morningstar2d
Biogen, Eisai: CHMP Reaffirms Backing of Leqembi Alzheimer's Drug
The CHMP last July recommended against approval of Leqembi, citing safety and efficacy issues, but Biogen and Eisai asked the panel to take another look, and the CHMP in November reversed course ...
The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its ...
Morningstar2d
The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
After reviewing the additional information, the CHMP concluded that its positive opinion for lecanemab does not need to be updated. Leqembi is a Aβ monoclonal antibody that preferentially binds ...
pharmaphorum5d
In shock move, EU panel rejects Alzheimer's drug Leqembi
The CHMP also concluded that, after 18 months of treatment, the benefit seen with Leqembi on CDR-SB – a 1.21-point increase with the drug versus a 1.66-point rise with placebo – represented a ...
Le Lézard2d
The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has ...