European Committee Takes a Second Look at Alzheimer's Drug

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.
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 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
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.
Eisai receives positive CHMP opinion for Lecanemab in early Alzheimer’s disease
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
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Ozempic and Viagra, among the more than 80 drugs expected to work against Alzheimer's in the coming years
Today, the first monoclonal antibodies, lecanemab and donanemab, are available, showing that their reduction effect on ...
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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.
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Leqembi: Side Effects No Worse in Clinical Use Than They Were in Trial
In Japan, clinical use is climbing faster, with about 4,500 people now on the drug. ARIA rates in Japan are half those in the U.S., which was also the case in the Phase 3 Clarity trial. Meanwhile, use ...
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 ...
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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 ...
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Lecanemab Bested Three Other Antibodies at Binding Soluble Aβ Aggregates
Four anti-amyloid antibodies—lecanemab, aducanumab, gantenerumab, donanemab—cleared plaque from the brain in Phase 3 trials, but only two went on to receive traditional U.S. marketing approval. What ...
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 ...