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.
European Agency Switches to Recommending New Alzheimer's Drug
If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer's medicine available in the European Union region. According to the EMA, the recommendation excludes patients who carry two copies of the ApoE4 gene, considering higher risk of side effects such as swelling and bleeding in the brain.
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.
European watchdog partially approves new Alzheimer’s drug
Europe's medicines watchdog partially approved a marketing request for a long-awaited new treatment for Alzheimer's disease
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.
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
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.
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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European Medicines Agency reveals favoured cities for relocation
The European Medicines Agency has revealed a list of five cities that are preferred as its new location by staff after Brexit, following warnings of a public health disaster if EU leaders pick ...
European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...
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Aurobindo Pharma Subsidiary Receives GMP From European Medicines Agency For Biosimilars Facility
CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three ...
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 ...
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Neurizon Therapeutics receives positive opinion on orphan medicinal product designation for NUZ-001 in Europe
Neurizon Therapeutics Limited (Neurizon), a clinical-stage biotech company advancing treatments for neurodegenerative diseases, announced it has received notice of a positive opinion from the ...