AMSTERDAM – The European Medicines Agency (EMA) has rejected a licence for an Alzheimer’s treatment which slows cognitive decline. The EMA said the benefits of lecanemab did not counterbalance the risk of serious side effects, especially bleeding and swelling in the brain.

The medicines regulator in the UK, the MHRA, is still considering whether to grant a licence, and a decision is expected soon. The drug was approved in the United States earlier this year.

In trials, lecanemab was shown to slow cognitive decline by about a quarter in patients in the early stages of Alzheimer’s. Alzheimer’s researchers hailed the trial results as “historic” because no previous drug had convincingly shown that the underlying mechanism of the disease could be slowed. Lecanemab works by clearing a rogue protein called amyloid, which builds up in the brains of Alzheimer’s patients.

Even if the drug was to be approved in the UK, it would then be up to health bodies – such as the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) – to decide whether the drug represents value for money and should be recommended to patients. Lecanemab costs about £20,000 per patient per year in the US. The EMA said that although patients given lecanemab, whose brand name is Leqembi, had delayed cognitive decline, the effects were small.

It said the most important safety concern was the frequent occurrence of amyloid-related imaging abnormalities (ARIA), that involve swelling and bleeding in the brain. The EMA said: “Although most cases of ARIA in the main study were not serious and did not involve symptoms, some patients had serious events, including large bleeds in the brain which required hospitalisation.” Overall it found the benefits of the treatment were not enough to outweigh the risks. (BB)…[+]