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 ...

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

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

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.

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

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

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 CHMP last July recommended against approval of Leqembi, citing safety and efficacy issues, but Biogen and Eisai asked the panel to take another look, and the CHMP in November reversed course ...

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 ...