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. He can be contacted at connect@pharmashots.com