BioArctic and Eisai Receives MAA from MHRA for Leqembi (lecanemab) to Treat Early Alzheimer’s Disease (AD) in Great Britain
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- The MHRA approved Leqembi (lecanemab) for adults with mild cognitive impairment (MCI) and mild dementia (MD) due to AD that are apolipoprotein E ε4 (ApoE ε4)
- The approval was based on a P-III (Clarity AD) study of Leqembi (10 mg/kg, Q2W) with MCI and MD due to AD having amyloid pathology (n=1,795) and ApoE ε4 heterozygotes or non-carriers pts. (n=1,521). Achieved its 1EPs, at 18 mos. (Leqembi vs PBO) reduced by 33% in CDR-SB and 1.15 vs 1.73 in adjusted least-squares mean change(18wks.), reached all the key 2EPs
- ApoE ε4 heterozygotes or non-carriers pts. having adverse reactions i.e, 26% in infusion-related, 13% in ARIA-H, 9% in ARIA-E & 11% in fall & headache. Leqembi is approved in around 8 countries and submitted the application in 10 countries
Ref: BioArctic | Image: BioArctic & Eisai
Related News:- Eisai and Biogen’s Leqembi (Lecanemab) Receives the NMPA’s Approval for the Treatment of Alzheimer’s Disease
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com