Alzheimer’s Drug Lecanemab Rejected in Europe

The European Medicines Agency (EMA) has denied approval for lecanemab, a drug being currently developed to help against Alzheimer’s. It has been reported that the drug has been showing the ability to start slowing cognitive decline. However, the EMA also concluded that there are indeed some risks and possible severe side effects such as brain bleeding and swelling.

According to the BBC, “Lecanemab works by clearing a rogue protein called amyloid, which builds up in the brains of Alzheimer’s patients.” No prior medication had definitively demonstrated the ability to slow the disease’s underlying mechanism.

Furthermore, the EMA has decided that the current benefits of the lecanemab drug do not outweigh the drug’s more critical side effects. Lecanemab has also been marketed as Leqembi in certain markets.

The drug works by targeting and clearing amyloid protein, which accumulates in the brains of Alzheimer’s patients. Despite its potential, the EMA highlighted concerns over amyloid-related imaging abnormalities (ARIA), which involve swelling and bleeding in the brain. While many cases of ARIA were asymptomatic, some resulted in severe complications requiring hospitalization.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still reviewing lecanemab, and a decision is expected soon. If approved in the UK, further evaluations by health bodies like NICE and SMC would determine its cost-effectiveness and recommendation for patients.

According to CNBC, the U.S. Food and Drug Administration approved Leqembi last year, but its rollout has been slow due to obstacles like diagnostic test requirements, frequent brain scans, and other challenges. Leqembi has also received regulatory approvals in countries including Japan, China, South Korea, and Israel.