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

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

BioArctic AB (publ) announced that the US Food and Drug Administration (FDA) has accepted BioArctic’s partner Eisai’s Biologics License Application (BLA) for Leqembi subcutaneous ... and insoluble ...

However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of catalysts” that could accelerate Leqembi’s growth in 2025. Since its approval in 2023, the launch of the ...

Jan 15, 2025 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for ...

Biogen Hits Lowest Stock Price Since 2013 as Leqembi Uptake Lags Biogen CEO Chris Viehbacher at JPM25 said that the pharma remains fully committed to the Alzheimer’s disease space and its therapeutic ...

Two years ago, Biogen and partner Eisai secured accelerated FDA approval for their Alzheimer’s med Leqembi, followed by a full approval in 2023. Since then, the companies have been gradually ...

STOCKHOLM, Jan. 14, 2025 /PRNewswire/ --BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's ...

The company's future hinges on the success of key products like Leqembi for Alzheimer's disease and Skyclarys for Friedreich's ataxia, while grappling with an underdeveloped pipeline and a ...

The agency has set a Prescription Drug User Fee Act (PDUFA) action date for the weekly autoinjector form of Leqembi for 31 August 2025. Eisai and Biogen’s antibody is currently infused every two ...

Acceptance of the Biologics License Application for subcutaneous Leqembi is based on results from the Clarity ... to be two times as likely than older whites to have AD or other forms of dementia. Due ...

On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly ...