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2w ago

FDA Approves Weekly Leqembi Autoinjector for At-Home Maintenance in Early Alzheimer’s

Safety monitoring requirements remain in place following recent FDA warnings on ARIA.

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The new injection will be available to early Alzheimer’s patients who are moving onto maintenance dosing. Credit: ahmetmapush via Shutterstock.com.

Overview

  • Eisai and Biogen will launch Leqembi IQLIK in the U.S. on October 6, 2025 at a list price of $375 per weekly injection, or $19,500 per year.
  • The weekly pen is for patients who have completed 18 months of intravenous Leqembi and are moving to maintenance dosing, with monthly IV infusions still available.
  • The approval draws on CLARITY AD data showing no efficacy loss when patients switch to the autoinjector after induction, with safety evaluated in an open-label cohort of more than 600 participants.
  • Following an August 28 safety notice, the FDA required an earlier MRI between the second and third IV dose due to ARIA risks that have included reported deaths.
  • The 360 mg device delivers a dose in about 15 seconds for at-home use, which the companies say could ease infusion-center bottlenecks and expand capacity for new treatment starts.