EMA: No to Lecanemab
Lecanemab is refused marketing authorization by the European Medicines Agency
Stephanie Vine | | 3 min read | News
Despite being approved in the US, Japan, South Korea, and a handful of other countries, lecanemab (Leqembi) has been refused marketing authorization by the EMA for the treatment of Alzheimer’s disease because the agency does not believe that the benefits of the treatment outweigh the risks.
“EMA’s human medicines committee, the CHMP, considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious adverse events associated with the medicine,” said a statement from the agency.
Perhaps the most serious side effect associated with the medicine is the potential for swelling and bleeding in the brain. The CHMP added that the risk of amyloid-related imaging abnormalities seemed higher in people with a certain gene – which also makes them more susceptible to Alzheimer’s disease and more likely to be eligible for treatment with lecanemab.
Eisai says it will seek a re-examination of the opinion.
Researchers responding to the news have landed on either side of the fence. Sebastian Walsh, NIHR Doctoral Fellow at the University of Cambridge (UK) said, “Though this decision will disappoint some patients and their families, I think it is a responsible one given the available evidence. The EMA rejection is based upon their view that small reduction in the amount of cognitive decline experienced over 18 months in the trial was not a clear enough benefit to justify the side effects experienced. Further challenges for these drugs come when you consider that the people in the drug trials were very carefully selected, and most patients in real-world settings have more complex disease, which may reduce the expected benefit, and increase the likelihood of side effects.”
Bart De Strooper, Professor in Alzheimer’s Disease at UCL and UKDRI, however, was more critical: “This outcome highlights a significant cultural disparity in how risk and innovation are perceived across different regions. While Europe tends to view the glass as half-empty, countries such as the USA, China, and Japan see it as half-full.
“This conservative approach means that patients and doctors eager to explore a proven effective drug are now denied access. With no current therapies available, it’s disheartening to think that if we had applied such caution in the past, particularly with cancer drugs and their severe side effects, we might still be without cancer treatments today.”
Lecanemab is currently under review with other regulators, including Swissmedic (Switzerland) and the MHRA (UK). In the phase III Clarity AD study, the drug met all primary and secondary endpoints.
In a statement, Tara Spires-Jones, President of the British Neuroscience Association, Director of the Centre for Brain Science Discovery at the University of Edinburgh and Group Leader at the UK Dementia Research Institute, added, “The EMA’s decision will come as a disappointment to many, but there are 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.”
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