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UK Authorizes Once-Every-Four-Weeks IV Maintenance Dosing of Leqembi for Early Alzheimer’s

The decision offers a less frequent infusion option for eligible early‑stage patients following the initial 18‑month schedule.

Overview

  • After 18 months at 10 mg/kg every two weeks, patients may switch to 10 mg/kg every four weeks for IV maintenance or remain on the biweekly regimen.
  • In the UK, Leqembi was previously cleared for adults with mild cognitive impairment or mild dementia due to Alzheimer’s who are ApoE ε4 heterozygotes or non‑carriers.
  • The label expansion rests on Phase 3 Clarity AD results, where lecanemab met its primary endpoint and all key secondary endpoints with statistical significance.
  • IV maintenance dosing following the initial phase is now approved in the UK, the United States, China, and other markets, reflecting broader global uptake.
  • In the United States, Leqembi Iqlik is authorized for subcutaneous maintenance with an autoinjector, and a rolling FDA submission for subcutaneous initiation dosing began in September 2025.