European Medicines Agency Rejects Lecanemab Alzheimer’s Drug Over Safety Concerns, Despite Potential Cognitive Benefits
Fiona Nanna, ForeMedia News
6 minutes read. Updated 10:12AM GMT Sat, 27July, 2024
In a significant development of Alzheimer’s research, the European Medicines Agency (EMA) has denied a license for the Alzheimer’s treatment, lecanemab, which was designed to slow cognitive decline. The decision marks a pivotal moment in the ongoing battle against Alzheimer’s disease, raising questions about the future of the drug in Europe.
Safety Concerns Overweigh Benefits
The EMA’s ruling was influenced by concerns regarding the safety profile of lecanemab, known commercially as Leqembi. Despite the drug’s potential to slow cognitive decline by approximately 25% in patients in the early stages of Alzheimer’s, the agency concluded that the benefits did not outweigh the risks of serious side effects. These risks include severe bleeding and swelling in the brain, conditions collectively referred to as amyloid-related imaging abnormalities (ARIA).
The EMA’s evaluation revealed that while the majority of ARIA cases in clinical trials were not symptomatic, some patients experienced serious events, such as large bleeds requiring hospitalization. Consequently, the EMA determined that the risks associated with lecanemab were too substantial given the modest benefits.
UK’s MHRA Decision Pending
In contrast to the EMA’s decision, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still deliberating whether to grant a license for lecanemab. A decision from the MHRA is anticipated in the near future. Meanwhile, lecanemab has already received approval in the United States earlier this year, adding a layer of complexity to the drug’s international regulatory landscape.
Financial Implications and Future Prospects
Should the drug receive approval in the UK, it will still face evaluation by health bodies such as the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). These organizations will determine whether lecanemab offers value for money and should be recommended for patient use. The cost of lecanemab in the United States is approximately £20,000 per patient annually, which adds to the financial considerations for potential adoption.
Reactions from the Scientific Community
Prof. Tara Spires-Jones, President of the British Neuroscience Association, expressed disappointment over the EMA’s decision but maintained optimism about the progress made. “Lecanemab has demonstrated that slowing down disease progression is possible, and research continues to be vital. Our focus must now shift towards discovering new and safer treatments,” she said.
Similarly, Prof. John Hardy from the UK Institute for Dementia Research at University College London (UCL) warned that the decision might have unintended consequences. “There is a concern that individuals with early-stage Alzheimer’s may seek treatment in countries where lecanemab is approved, creating disparities in access,” he noted.
A Turning Point in Alzheimer’s Treatment
The BBC’s Panorama program, which followed patients on lecanemab and another new drug, donanemab, highlighted the transformative potential of these treatments. Prof. Cath Mummery from the Dementia Research Centre at UCL described the drugs as representing a “turning point” in Alzheimer’s treatment, despite the small scale of their benefits.
The Alzheimer’s Society acknowledged the EMA’s decision but emphasized the importance of ongoing research. Mark MacDonald from the society remarked, “This news is challenging for individuals in Europe who might have been eligible for lecanemab. However, with 164 active clinical trials for Alzheimer’s disease, we remain hopeful for future advancements.”
