Eisai and Biogen Reports the CHMP’s Positive Opinion of Lecanemab to Treat Early Alzheimer’s Disease
Shots:
- The CHMP has recommended lecanemab to treat mild cognitive impairment & mild dementia in AD patients with confirmed amyloid pathology. Final decision from the EC is expected within 67 days
- Opinion was based on the P-III (Clarity AD) study of lecanemab (10mg/kg, bi-weekly) vs PBO in early AD patients (n=1,795) of which 1,521 were in indicated population (ApoE ε4 non-carriers or heterozygotes)
- Study showed reduced clinical decline on the CDR-SB scale (1EP) by 31% in the indicated population, with a mean baseline score of 3.2 & adjusted least-squares mean change of 1.217 vs 1.752 at 18mos. A decline on the ADCS-MCI-ADL scale (2EP) by 33% was seen at 18mos., with adjusted mean changes of −3.873 vs −5.809
Ref: Biogen | Image: Biogen
Related News:- BioArctic and Eisai Receives MAA from MHRA for Leqembi (lecanemab) to Treat Early Alzheimer’s Disease (AD) in Great Britain
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
