The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatmentAlzheimer's disease progression does ...

The U.S. Food and Drug Administration approved Eisai and Biogen’s application for IV maintenance dosing of lecanemab on January 27. Previously, the label called for biweekly IV dosing. The new ...

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi, a monoclonal antibody ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two ...

The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...

The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been ...

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...

1,2,3 Only LEQEMBI works to fight AD in two ways ... the mean change from baseline between the once every two weeks lecanemab treated group and the placebo group was -0.45 (P<0.0001) on the ...

Eisai has submitted applications for approval of lecanemab in 17 countries and regions. Additionally, the FDA accepted Eisai’s Supplemental Biologics License (BLA) for the LEQEMBI subcutaneous ...