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Eisai Files sBLA for Lecanemab-irmb Maintenance Dose, Reports Delay on SC Formulation / image credit Alzheimer disease concept: ©Zerbor/stock.adobe.com
UPDATE 6-11-2024: Eisai Files sBLA for Lecanemab-irmb Maintenance Dosing

June 11th 2024

The FDA has assigned a PDUFA action date of January 25, 2025 for the monthly IV maintenance dose.

Eisai Announces Submission of Rolling BLA for SQ Autoinjector-Delivered Lecanemab image credit dementia ©Billion Photos/Shutterstock.com
Eisai Announces Submission of Rolling BLA for SQ Autoinjector-Delivered Lecanemab

May 16th 2024

Donanemab FDA AdComm Hearing Scheduled for June 10, Eli Lilly Says
Donanemab FDA AdComm Hearing Scheduled for June 10, Eli Lilly Says

May 8th 2024

Eli Lilly has announced that the US Food and Drug Administration's (FDA)  Peripheral and Central Nervous System Drugs Committee will convene for a meeting to deliberate over its antiamyloid therapy donanemab, and the supportive phase 3 TRAILBLAZER-ALZ 2 trial (NCT04437511).1 The date of the advisory meeting has yet to be set by the FDA, and, as a result, the timing of expected FDA action for the treatment will be delayed beyond the first quarter of 2024.1
Lilly Investigational Alzheimer Agent Donanemab Phase 3 Findings Under FDA Review

March 8th 2024

/ image credit Amyloid plaque: ©Artur/stock.adobe.com
Plasma Immunoassay for Alzheimer Disease Found Highly Accurate and is Commercially Available

February 29th 2024

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