European regulators initially said in July that the drug's benefits did not outweigh its risks. View on euronews ...

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.

After re-examining its initial opinion, EMA’s human medicines committee, or CHMP, has recommended granting a marketing authorisation to Leqembi for treating mild cognitive impairment or mild dementia ...

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...

Raymond James analyst Danielle Brill says the news that the European Medicines Agency’s CHMP reversed course and issued a positive recommendation for the marketing authorization of Leqembi in the EU ...

The adjustment comes after a reassessment of the anticipated performance of Biogen's Alzheimer's treatment, Leqembi. The launch of Leqembi has not met the expectations set by analysts, leading to ...

The adjustment comes after a reassessment of the anticipated performance of Biogen's Alzheimer's treatment, Leqembi. The launch of Leqembi has not met the expectations set by analysts, leading to ...

Eisai Co (ESAIY) and Biogen Inc. (BIIB) announced that the latest findings for lecanemab-irmb, an anti-amyloid beta protofibril* antibody for the treatment of early Alzheimer’s disease, were ...

STOCKHOLM, Oct. 30, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi during the third quarter 2024 ...

The company also raised its full-year profit guidance. Sales of its breakthrough Alzheimer's drug, Leqembi, along with new rare disease and depression treatments, helped offset a year-over-year ...