Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

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.

Eisai and Biogen have been unable to persuade the medicines regulator in Australia to approve their Alzheimer's disease ...

LEQEMBI (lecanemab) has significant market potential due to the high global prevalence of the condition and the demand for disease-modifying treatmen ...

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 ...

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 ...

The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's ...

The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.

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 2024.

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 ...

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 ...