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 maintenance dosing. Leqembi is indicated for Alzheimer’s disease in patients with Mild Cognitive Impairment or mild dementia stage of the disease. A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025. The BLA is based on data from th…

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FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi - Biogen (NASDAQ:BIIB)

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Since its approval in 2023, the Alzheimer's disease drug made by Biogen Inc. and Eisai Inc. has seen a lackluster launch. However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of catalysts” that could accelerate Leqembi’s growth in 2025.

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Biogen lays out three FDA decisions that could ramp up Alzheimer's drug launch

Eisai Co., and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for the lecanemab-irmb subcutaneous autoinjector (SC-AI), branded as LEQEMBI in the U.S. This BLA submission is for weekly maintenance dosing to treat Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia, collectively referred to as early AD. The FDA has set a Pr…

Express Pharma

FDA accepts Eisai’s BLA for LEQEMBI subcutaneous autoinjector for alzheimer’s disease treatment - Express Pharma

LEQEMBI autoinjector could become first at-home subcutaneous Alzheimer's treatment, offering 15-second weekly maintenance doses. FDA decision expected August 2025.

stocktitan.net

FDA Accepts Eisai-Biogen's Revolutionary At-Home Alzheimer's Treatment Application for Review

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 Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosingLeqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of dise…

pressreach.com

FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US - PressReach

The PDUFA action date for the more convenient autoinjector is set for August 2025.

pharmaceutical-technology.com

Eisai and Biogen’s subcutaneous Leqembi set for FDA review - Pharmaceutical Technology

In the pivotal phase 3 Clarity AD trial, treatment with a subcutaneous autoinjector of lecanemab led to reduced rates of amyloid-related imaging abnormalities while maintaining similar bioequivalence levels to the original formulation.

neurologylive.com

FDA Accepts BLA for Subcutaneous Autoinjector Formulation of Lecanemab

If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The FDA has set a goal date of Aug. 31, 2025.

Managed Healthcare Executive

FDA Accepts BLA for Leqembi Autoinjector

The lates update in lecanemab’s journey: the FDA has accepted the BLA for lecanemab-irmb subcutaneous autoinjector for weekly maintenance dosing.

FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi - Biogen (NASDAQ:BIIB)

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