Europe (Washington Insider Magazine) – The European Medicines Agency (EMA) has rejected a licence for an Alzheimer’s treatment which slows cognitive decline. The EMA concluded that the drug’s benefits did not sufficiently outweigh the risks of serious side effects, particularly brain bleeding and swelling.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still evaluating lecanemab, with a decision anticipated soon. The drug, approved in the United States earlier this year, demonstrated in trials a 25% reduction in cognitive decline for early-stage Alzheimer’s patients.
Mechanism and Costs
Lecanemab acts by removing amyloid, a renegade protein that builds up in the brains of people suffering from Alzheimer’s disease. Because lecanemab delays the onset of sickness, researchers have hailed it as a breakthrough. Nonetheless, each patient’s annual cost of the medication in the US is roughly £20,000. Health institutions like the Scottish Medicines Consortium (SMC) and the National Institute for Health and Care Excellence (NICE) would need to assess whether a medicine is cost-effective and should be administered to patients even if it has a license in the UK.
Safety Concerns
The EMA highlighted that while lecanemab showed delayed cognitive decline, the effects were modest. The primary safety concern involved amyloid-related imaging abnormalities (ARIA), which include brain swelling and bleeding. Some ARIA cases required hospitalization due to serious brain bleeds. Ultimately, the EMA found the treatment’s risks outweighed its benefits.
According to BBC, Prof Tara Spires-Jones, president of the British Neuroscience Association, acknowledged the decision as disappointing but emphasized the importance of continued research for safer treatments. Prof John Hardy of University College London expressed concern that wealthy patients might seek treatment abroad in response to the decision.
The BBC’s Panorama program, which followed patients on lecanemab and another new drug, donanemab, featured Prof Cath Mummery from the Dementia Research Centre at UCL. She described the drugs as a significant turning point, demonstrating for the first time that Alzheimer’s disease progression can be altered.
Mark MacDonald from the Alzheimer’s Society respected the EMA’s decision but recognized the difficulty for potential European patients. He highlighted the broader context, noting the ongoing 164 active clinical trials for Alzheimer’s disease and the anticipation of more treatments seeking MHRA approval in the future.