FDA approves leqembi IV maintenance dosing for early Alzheimer's treatment
- The FDA approved a supplemental biologics license application for lecanemab-irmb (Leqembi) for once every four weeks IV maintenance dosing.
- Leqembi is indicated for early Alzheimer's disease in patients with mild cognitive impairment or mild dementia.
- The approval is based on data from Phase 2 and Clarity AD studies, showing maintained clinical and biomarker benefits.
- Leqembi is approved in multiple countries, with ongoing applications in 17 regions.
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