The European Union’s drugs regulator reversed its decision to block the Alzheimer’s drug lecanemab, a treatment aimed at slowing cognitive decline in patients.
In July, the Amsterdam-based European Medicines Agency (EMA) denied recommending approval of the drug made by Eisai and Biogen because it considered the risks – especially bleeding and swelling in the brain – to be greater than the potential benefits in a broad population.
The makers requested a second review, the results of which were issued on Thursday.
The EMA said that after re-examining its initial opinion, it has concluded that some people in the early stages of the disease could be helped by the drug. The regulator is requiring patients undergo MRI scans at various stages of their treatment to check for abnormalities.
Lecanemab, sold under the brand name Leqembi, would be the first drug on the market in the EU to target the underlying disease processes of Alzheimer’s rather than just treat the symptoms.
The European Commission, which is responsible for marketing authorization, usually follows the opinion of the agency.
The drug is already authorized in the United States and Britain, but not in Australia.
Swiss
