Eisai and Biogen’s subcutaneous Leqembi set for FDA review
Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration (FDA) accepted a biologics licence application (BLA) for a subcutaneous version of the drug.
Biogen, Eisai say injectable Alzheimer’s therapy granted FDA review
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) announced that the U.S. Food and Drug Administration (FDA) accepted a marketing application for an injectable version of their Alzheimer’s therapy lecanemab.
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
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.
Biogen/Eisai announce FDA BLA acceptance for injectable Alzheimer’s drug
Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for an injectable formulation of their Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb).
FDA accepts Eisai/Biogen’s BLA for LEQEMBI in early AD treatment
Eisai (ESAIY) and Biogen (BIIB) announced that the FDA has accepted Eisai’s Biologics License Application, BLA, for
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Analysts tip Eisai, Biogen and Lilly to drive eightfold explosion in Alzheimer's market value
GlobalData analysts are predicting an Alzheimer’s disease market boom, tipping its value across major regions to increase ...
Healio2d
FDA grants biologics license application for monthly IV Leqembi
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...
BioSpace3d
Could New Leqembi Formulations Boost Lagging Sales in Alzheimer’s?
The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an ...
FDA Accepts Eisai And Biogen's BLA For Subcutaneous LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has accepted Eisai's Biologics ...
Yahoo Finance3d
Eisai Co., Ltd. (ESAIY)
Eisai Inc. announced today that screening for Study E2086-A001-101 (Study 101) to assess the efficacy, safety and tolerability of E2086, a novel selective orexin-2 receptor, is now registered on ...
pharmaphorum3d
Eisai dials back forecasts for Alzheimer's drug Leqembi
Eisai has retreated from the optimistic view of sales growth for Alzheimer's disease drug Leqembi it held earlier this year as uptake remains sluggish. In its six-month financial report for the ...