European Committee Takes a Second Look at Alzheimer's Drug

European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at slowing cognitive decline in patients. In July, the Amsterdam-based European Medicines Agency (EMA) denied recommending approval of the drug made by Eisai and Biogen because it considered the risks - especially bleeding and swelling in the brain - to be greater than the potential benefits in a broad population.
European agency switches to recommending new Alzheimer's drug
The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval of sales of lecanemab to treat Alzheimer's disease. The committee of the pharmaceuticals watchdog had shown a negative opinion in July on the medicine, developed by drugmakers Eisai of Japan and Biogen of the United States.
European watchdog partially approves new Alzheimer's drug
"After re-examining its initial opinion, the EMA... has recommended granting marketing authorisation to Leqembi (lecanemab) for treating mild cognitive impairment or mild dementia due to Alzheimer's disease," the European Medicines Agency said, adding ...
EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval for Eisai and Biogen's Leqembi in some patients with early Alzheimer's disease, nearly four months after it first rejected the treatment.
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
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EMA committee rethinks stance and 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.
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Ozempic and Viagra, among the more than 80 drugs expected to work against Alzheimer's in the coming years
For now, after obtaining approval for early stages of cognitive decline and dementia, lecanemab and donanemab continue ...
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Alzheimer's Data Withdrawn
A preprint research letter linking the Alzheimer's drug lecanemab (Leqembi) with excess deaths was withdrawn last week. The ...
The Lancet23h
Amyloid-lowering treatment in Alzheimer's disease
We fully endorse the Editorial1 on the negative opinion of the European Medicines Agency of the use of lecanemab for the treatment of early Alzheimer's disease. Investigators from the European ...
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 a positive recommendation regarding BioArctic's partner Eisai ...
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 ...