FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 14 2025
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Source: Yahoo Finance
FDA Approval for Leqembi: The FDA has accepted a Biologics License Application for BioArctic's partner Eisai's subcutaneous autoinjector of Leqembi, an Alzheimer's treatment, which allows for at-home administration and is set for action by August 31, 2025.
Clinical Background and Collaboration: Leqembi, developed through a collaboration between BioArctic and Eisai, is already approved in multiple countries and is based on positive Phase 3 clinical trial results, with ongoing studies for further applications in Alzheimer's disease.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
