The European Medicines Agency (EMA) has refused to approve lecanemab, the controversial new drug against Alzheimer’s, after analysing the results of clinical trials with patients suffering from early dementia.
The panel of experts of The agency has recommended on Friday to refuse to grant marketing authorisation to Leqembi, the trade name for lecanemab. The committee considers that the observed effect in delaying cognitive decline does not outweigh the risk of serious side effects associated with the drug, in particular the frequent appearance of imaging abnormalities related to the amyloid protein (ARIA), which involve swelling and bleeding in the brain.
Two years ago, the first results of lecanemab were greeted with euphoria, as it was the first drug in decades to offer some benefit to patients with Alzheimer’s, a disease for which there is currently no cure and whose causes are unclear. The condition affects 50 million people and their relatives worldwide.
The drug targets amyloid, one of the proteins that accumulate in the brain and that could have some effect on the progression of the disease. The first results showed that this antibody reduced cognitive decline by 27%, according to a clinical trial with 1,700 patients in several countries, including Spain. The effect was so modest that probably neither the patients nor their caregivers would notice the effect. These results were added to several cases of brain inflammation, hemorrhages and the death of at least two patients.
In winter of this year, the US drug agency authorized the use of this drug on an emergency basis, and then confirmed its full approval in July. In November 2022, a study showed that the drug reduced the size of the brains of patients, although the reasons for this reduction were not clear. the causes. Despite this, the manufacturers decided to go ahead with the approval of the antibody. Many eyes were now focused on whether the European agency would endorse the decision of the American agency regarding this drug, developed by the pharmaceutical companies Eisai and Biogen. Finally, today, the committee for medicinal products for human use has recommended not giving the go-ahead to this drug due to its possible adverse effects.
Monoclonal antibodies are among the most expensive drugs in the world. Aducanumab — a lecanemab-like antibody developed by Biogen against Alzheimer’s disease that failed — cost $56,000 per patient.
One of the major challenges posed by lecanemab, and others of its kind, such as donanemab, which reduces cognitive decline by 35% and is still being evaluated, is that the first signs of dementia had to be detected very early and the drug applied for life in order to have obvious effects. This poses challenges and costs in diagnosis and treatment that few health systems could afford. In Spain, for example, the use of lecanemab could overwhelm the capacity of the system, according to some experts. Last month, the FDA approved donanemab, developed by the pharmaceutical company Lilly, for the treatment of early Alzheimer’s. The EMA is currently analyzing this application.
“It is not a surprising decision given the safety issues with the drug,” explains David Pérez, a neurologist at the Hospital 12 de Octubre in Madrid, to this newspaper. “I think it is a very cautious decision pending long-term results,” he adds.
Eva Carro, principal investigator at the Biomedical Research Network on Neurodegenerative Diseases, explains to this newspaper: “In recent months there have been many critical voices against this drug among doctors and basic researchers.” “The very limited efficacy did not in any case compensate for the side effects that occurred at the vascular level. It was difficult to argue why it should be supported. In addition, the beneficial effect is only a very limited slowing of cognitive decline. There are studies that show that the same effect is achieved with non-pharmacological therapies, such as cognitive training and food supplements,” she highlights.
Other experts have expressed a similar opinion, albeit with clear disappointment. “I am disappointed with the decision not to license Lecanemab for the treatment of Alzheimer’s disease,” he explained. John Hardya neuroscientist at University College London, told specialist portal SMC. “The question of whether the undoubted statistical benefit of the treatment is worth the risk of serious, albeit rare, side effects is always difficult with any treatment and on this occasion the EMA and FDA have come to different conclusions when presented with similar data. I am sure we will now see wealthy people with early Alzheimer’s flying to the US or other jurisdictions to receive treatment. I assume this decision will be revisited as US clinicians and others gather real-world data with lecanemab and donanemab,” he added.
Tara Spiers-Jonesfrom the UK Institute for the Study of Dementia, has acknowledged that “the EMA decision will be a disappointment for many, but there are reasons to remain hopeful.” “Lecanemab has shown that it is possible to slow the progression of the disease, and research does work. We now need to step 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 communication between neurons. Each discovery brings us closer to new and better treatments,” he added.
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