It was not unexpected, but it is still very exciting news! The U.S. Food and Drug Administration (FDA) has granted traditional approval to Leqembi (lecanemab-irmb), a treatment for Alzheimer's disease. This decision follows a confirmatory trial that verified its clinical benefit. "The drug works by reducing amyloid plaques, a hallmark of Alzheimer's disease" - FDA
Professor James Rowe, DPUK's Associate Director for Experimental Medicine and Professor of Cognitive Neurology at the University of Cambridge, said that the FDA's decision and highlighted the need for the UK to prepare for the delivery of disease-modifying treatments. He stressed the importance of addressing issues related to diagnosis, genotyping, access to MRI scans, and establishing specialised healthcare staff and facilities for advanced therapies.
"This is a very important decision by the FDA. It highlights the need for the UK to plan now to be able to deliver disease-modifying treatments for people Alzheimer’s disease. There is much to be done if lecanemab and similar drugs are to be accessible with safety and equity – better diagnosis, genotyping and issues that raises, improved MRI access, and the specialist NHS staff and sites to safely administer advanced therapies.
In the UK, we need MHRA and NICE to complete their reviews on lecanemab with the urgency that is felt by so many families. The FDA has not made the decision lightly. The evidence on Lecanemab includes practical information on caveats and risks, to help clinicians and patients make individual decisions.
This FDA decision will increase the accessibility of lecanemab in the US. There is still much to be learnt about the drug and its long term effects. But one thing we have all learnt is that investment in dementia research delivers results. "
Dr Ivan Koychev, Senior Clinical Researcher, Dementia Platform UK, University of Oxford, also said:
“The full approval of lecanamab signals a step change in the treatment of Alzheimer’s disease. It clears the amyloid proteins that are part of the Alzheimer’s process and the approval rests on data from studies showing some modest decrease in the rate at which patients decline. Concerns remain about the safety and deliverability of these therapies; in the UK for example the drug would require a complete overhaul of the memory clinics to allow intravenous drug administration, genetic testing to determine those most likely to experience side effects and serial MRI head scanning to monitor for side effects. While these issues will undoubtedly limit the access to the drug itself, this new frontier in the treatment of Alzheimer’s disease will stimulate investment in the area to further refine treatments that change the disease process and will make the case for investment in non-pharmacological programmes for prevention of the disease in people at risk.”
While the FDA's approval expands access to Leqembi in the United States, further research is required to understand the drug's long-term effects. However, this decision underscores the importance of investing in dementia research, as it has the potential to promising outcomes.