Today, the European Medicines Agency has made the decision not to approve lecanemab for the treatment of Alzheimer's disease in the EU. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has yet to make a decision on the drug. Here, UK DRI researchers comment on today's news.
Prof Nick Fox, Group Leader at the UK DRI at UCL, said:
"It is disappointing that the EMA has has not approved lecanemab. Lecanemab is not a cure, but there is clear evidence that it can slow clinical progression in early-stage Alzheimer’s disease - with a 27% slowing having been shown. This equates to a saving of around five months over an 18 month treatment period. Delaying clinical decline and maintaining functional independence when people are in the milder stages of this disease is what matters to patients and families. The EMA, unlike the US FDA, decided that these benefits did not outweigh the risks associated with lecanemab. Lecanemab is now being prescribed in the US and Japan and several other countries - hopefully as real-world experience of using this therapy accumulates this will provide evidence that the risks are manageable and the EMA decision will be revisited. In the meantime the DRI, alongside global research efforts, will continue to advance our understanding of the diseases that cause dementia and find effective therapies for these devastating disorders."
Prof Bart De Strooper, Group Leader at the UK DRI at UCL, said:
“I regret to read the unfortunate yet not unexpected decision regarding the approval of Lecanemab/Lequembi. 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.
“Once again, Europe positions itself as a follower, allowing other nations to determine the optimal benefit-to-side-effect balance through practical use of Lecanemab in clinical settings. This decision marks a setback for patients and a blow to clinical research in a field long overlooked by Europe.
Today is a sombre day for the patients who could have benefited from Lecanemab and for the advancement of clinical research that has been stifled for too many years.”
Prof John Hardy, Group Leader at the UK DRI at UCL, said:
“I have to say I am disappointed in the decision to not grant a license to Lecanemab for the treatment of Alzheimer’s disease. The EMA (in contrast to the FDA) has taken the view that the risk of ARIA outweighs the clinical benefit. The imaging abnormality seen in treated patients is usually either without symptoms or with only minor, headaches as symptoms, but is occasionally associated with brain haemorrhages. The question of whether the undoubted statistical benefit of treatment is worth the risk of serious, though rare side effects is always difficult with any treatment and on this occasion the EMA in Europe and the FDA in the US have reached different conclusions when presented with similar data. I am sure we will now see rich people with early Alzheimer’s disease flying to the US or other jurisdictions for treatment. My guess would be that this decision will be revisited as US clinicians and others gather and report real world experience with both lecanemab and the (very similar) dononemab treatments.”
Prof Tara Spires-Jones, Group Leader at the UK DRI at Edinburgh, said:
“The Phase III clinical trial of lecanemab showed that it does what it’s supposed to; it reduces toxic amyloid in the brain and slows cognitive decline. Scientifically, this was an important step forwards. However, the size of the effect was modest, and coupled with that there were significant side effects, including swelling and brain bleeds leading to death in a few people.
“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. Scientists around the world are tackling this from different angles – from stopping toxic “tau” proteins moving through the brain, to protecting synapses, which allow neurons to communicate. Each discovery brings us closer to new and better treatments.”
Article published: 26 July 2024
Banner image: Shutterstock/Joshimerbin
