The European Medicines Agency (EMA) has rejected a licence for the Alzheimer’s treatment lecanemab (Leqembi), saying the benefits did not counterbalance the risk of serious side effects, especially bleeding and swelling in the brain.
The medicines regulator in Britain, 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, reports the BBC.
In trials, lecanemab was shown to slow cognitive decline by about a quarter in patients in the early stages of Alzheimer’s, results hailed by researchers as “historic” because no previous drug had convincingly shown that the underlying mechanism of the disease could be slowed.
Even if the drug were to be approved in the UK, it would then be up to health bodies – like 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.
Safety concerns
The EMA said that although patients given lecanemab had delayed cognitive decline, the effects were small, and that the most important safety concern was the frequent occurrence of amyloid-related imaging abnormalities (ARIA), that involve swelling and bleeding in the brain.
“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.
Professor Tara Spires-Jones, president of the British Neuroscience Association, said the EMA’s decision will come as “a disappointment to many”, but there were reasons to remain hopeful.
“Lecanemab has shown that it is possible to slow down disease progression, and research does work. Now we need to ramp up our efforts to discover new and safer treatments,” she said.
The Alzheimer’s Society said while it respected the decision on the drug, it would be “really difficult news for people in Europe who may have been eligible for this drug”.
Mark MacDonald, from the society, added that there were currently 164 active clinical trials for Alzheimer’s disease, “and we expect more treatments to be submitted for MHRA approval in the future”.
“Though this decision will disappoint some patients and their families, I think it is a responsible, one given the available evidence,” said Dr Sebastian Walsh, a National Institute for Health and Care Research Doctoral Fellow at the University of Cambridge.
Differences
“This outcome highlights a significant cultural disparity in how risk and innovation are perceived across different regions,” said Prof Bart De Strooper, professor of Alzheimer’s disease at University College London, who argues patients could be missing out on valuable treatments that could improve their quality of life.
“Today is a sombre day for those who could have benefited from lecanemab and for the advancement of clinical research that has been stifled for too many years,” he added.
“While Europe tends to view the glass as half empty, countries such as the USA, China and Japan, see it as half full.”
However, the cautious approach by the EMA has been praised by Prof Robert Howard, professor of old age psychiatry at University College London, who told Technology Networks: “Based on the clinical trial evidence of only very modest efficacy, that would just not be noticeable in an individual person with Alzheimer’s disease and that cannot be considered clinically meaningful by any objective measure, and the real risks of harms from brain swelling and bleeding, the EMA has made the right decision in my opinion.”
BBC article – EU regulator rejects Alzheimer’s drug lecanemab (Open access)
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