After re-examining its preliminary opinion, the European Medicines Company’s (EMA) human medicines committee (CHMP) has really helpful granting advertising and marketing authorisation to Leqembi (lecanemab) for treating gentle cognitive impairment (reminiscence and pondering issues) or gentle dementia as a consequence of early Alzheimer’s illness in sufferers who’ve just one or no copy of ApoE4, a type of the gene for the protein apolipoprotein E.
Sufferers with just one or no copy of ApoE4 are much less prone to expertise amyloid-related imaging abnormalities (ARIA) in comparison with these with two ApoE4 copies. ARIA is a recognised critical side-effect with Leqembi, marked by swelling and potential bleeding within the mind.
The CHMP concluded that within the restricted inhabitants assessed within the re-examination, the advantages of Leqembi in slowing the development of the signs of the illness are better than its dangers.
In July 2024, the committee had issued a unfavorable opinion on using Leqembi in a broader inhabitants of all sufferers with early Alzheimer’s illness.
The CHMP concluded that in sufferers who’ve one or no copy of ApoE4, the advantages outweigh the dangers in utilizing Leqembi to deal with gentle cognitive impairment or gentle dementia as a consequence of Alzheimer’s illness, offered that measures are in place to minimise the chance of extreme and symptomatic ARIA, and monitor its long-term penalties.
Leqembi will probably be out there via a managed entry programme to make sure the drugs is barely used within the really helpful affected person inhabitants. Sufferers might want to have MRI scans to watch for ARIA earlier than initiation of remedy and earlier than the fifth, seventh and 14th doses of Leqembi.
Extra MRI scans could also be wanted at any time throughout remedy if sufferers develop signs of ARIA (akin to headache, confusion, visible modifications, dizziness, nausea, and problem in strolling).
(Supply: EMA)
