Image source, Getty Images
- author, Fergus Walsh
- role, Medical Journalist
The European Medicines Agency (EMA) Denied license An Alzheimer’s disease drug that slows cognitive decline.
The EMA said the benefits of lecanemab do not offset the risk of serious side effects, particularly bleeding and swelling in the brain.
The UK’s medicines regulator, the MHRA, is still considering whether to grant approval, with a decision expected shortly. The drug was approved in the US earlier this year.
In trials, lecanemab was shown to slow cognitive decline by about a quarter in patients with the early stages of Alzheimer’s disease.
Alzheimer’s researchers praised Test results The drug is “historic” because no previous drug has been convincingly shown to slow the underlying mechanisms of the disease.
Lecanemab works by removing abnormal proteins called amyloid that build up in the brains of people with Alzheimer’s disease.
Even if the drug is approved in the UK, it will 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 it is cost-effective and should be recommended for patients.
In the US, lecanemab costs approximately £20,000 per patient per year.
Safety concerns
The EMA said patients given lecanemab, which has the brand name Leqembi, slowed cognitive decline but the effect was small.
The company said its most significant safety concern was the frequency of amyloid-related imaging abnormalities (ARIA), which involve swelling and bleeding in the brain.
“Most cases of ARIA in the main study were not serious and did not cause any symptoms, but some patients experienced severe symptoms, including massive bleeding in the brain requiring hospitalization,” the EMA said.
Overall, the benefits of treatment were found not to outweigh the risks.
Professor Tara Spires-Jones, president of the British Neuroscience Society, said the EMA’s decision “will come as a disappointment to many people”.
But she said there is reason to remain hopeful.
“Research is certainly working as lecanemab has shown it is possible to slow the progression of the disease. Now we need to intensify our efforts to find new, safer treatments,” Prof Spires-Jones said.
Prof John Hardy, professor of neuroscience and group leader at the Dementia UK Institute, University College London (UCL), said the decision could have unintended consequences.
“I’m sure that from now on, wealthy people with early-stage Alzheimer’s will fly to the US and other jurisdictions for treatment.”
“An exciting moment”
Speaking on the programme earlier this year, Professor Cath Mummery, consultant neurologist and clinical trial director at the Dementia Research Centre, University of London, said the drug’s effect was small but marked a “tipping point”.
She added: “I don’t think it’s a false hope. For the first time, we have a drug that shows we can change the course of Alzheimer’s disease. This is amazing.”
The Alzheimer’s Society said that while it respected the decision on the drug, “this will be really disappointing news for people in Europe who may have been eligible to receive this medicine.”
“Whatever decision regulators make, we remain at an important and exciting moment,” the association’s Mark McDonald said.
“There are currently 164 active clinical trials for Alzheimer’s disease, and we expect many more treatments to be submitted for MHRA approval in the coming days.”
