CHMP Reaffirms Backing of Leqembi Alzheimer's Drug

Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
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.
Australia stands firm on 'no' to Alzheimer's drug Leqembi
Eisai and Biogen have been unable to persuade the medicines regulator in Australia to approve their Alzheimer's disease therapy Leqembi, with a narrower label than originally proposed.
EC Resumes Review of Eisai, Biogen's Leqembi Application After CHMP Reaffirms Positive Opinion
The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.
EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug
The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's drug, Leqembi, after concluding a safety review.
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 positive opinion for the anti-Aβ monoclonal antibody lecanemab (Leqembi®),
Biogen, Eisai confirm CHMP positive opinion for lecanemab
Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has
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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 ...
LEQEMBI Market Sales Reflect Growing Confidence In Disease-Modifying Alzheimer’S Treatments| Delveinsight
LEQEMBI (lecanemab) has significant market potential due to the high global prevalence of the condition and the demand for disease-modifying treatmen ...
BioWorld3d
Leqembi gets another thumbs-up amid CHMP February recommendations
The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that ...
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Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
Image Source: Zacks Investment Research We remind the investors that the CHMP had earlier given a negative opinion regarding marketing approval for Leqembi for early Alzheimer's disease in July ...
The Committee For Medicinal Products For Human Use (CHMP) Reaffirms Positive Opinion For Lecanemab In Early Alzheimer's Disease
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ...