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.
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