Europe rejects controversial Alzheimer's drug lecanemab | Science | EUROtoday

The European Medicines Agency (EMA) has refused to approve lecanemab, the controversial new drug towards Alzheimer's, after analysing the outcomes of medical trials with sufferers affected by early dementia.

The company's panel of specialists really helpful on Friday to not grant advertising authorisation to Leqembi, the commerce title for lecanemab. The committee considers that the noticed impact in delaying cognitive decline doesn’t outweigh the chance of significant unwanted effects related to the drug, specifically the frequent look of imaging abnormalities associated to the amyloid protein (ARIA), which contain swelling and bleeding within the mind.

Two years in the past, the primary outcomes of lecanemab have been greeted with euphoria, because it was the primary drug in a long time to supply some profit to sufferers with Alzheimer's, a illness for which there’s presently no treatment and whose causes are unclear. The situation impacts 50 million individuals and their kinfolk worldwide.

The drug targets amyloid, one of many proteins that accumulate within the mind and that might have some impact on the development of the illness. The first outcomes confirmed that this antibody decreased cognitive decline by 27%, in response to a medical trial with 1,700 sufferers in a number of international locations, together with Spain. The impact was so modest that most likely neither the sufferers nor their caregivers would discover the impact. These outcomes have been added to a number of instances of mind irritation, hemorrhages and the dying of no less than two sufferers.

In winter this yr, the US drug company gave emergency use authorization for this drug, after which confirmed its full approval in July. In November 2022, a examine confirmed that the drug decreased the scale of sufferers' brains, though the causes weren’t clear. Despite this, the producers determined to go forward with the approval of the antibody. Many eyes have been now on whether or not the European company would endorse the choice of the US company concerning this drug, developed by the pharmaceutical firms Eisai and Biogen. Finally, at this time, the committee for medicinal merchandise for human use has really helpful not giving approval to this drug attributable to its doable antagonistic results.

Monoclonal antibodies are among the many costliest medicine on the earth. Aducanumab — a lecanemab-like antibody developed by Biogen towards Alzheimer's illness that failed — price $56,000 per affected person.

One of the key challenges posed by lecanemab, and others of its type, reminiscent of donanemab, which reduces cognitive decline by 35% and continues to be being evaluated, is that the primary indicators of dementia needed to be detected very early and the drug utilized for all times with a purpose to have apparent results. This poses challenges and prices in analysis and therapy that few well being techniques may afford. In Spain, for instance, using lecanemab may overwhelm the capability of the system, in response to some specialists. Last month, the FDA accredited donanemab, developed by the pharmaceutical firm Lilly, for the therapy of early Alzheimer's. The EMA is presently analyzing this software.

“It is not a surprising decision given the safety issues with the drug,” explains David Pérez, a neurologist on the Hospital 12 de Octubre in Madrid, to this newspaper. “I think it is a very cautious decision pending long-term results,” he provides.

Eva Carro, principal investigator on 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 specialists have echoed this opinion, albeit with clear disappointment. “I am disappointed with the decision not to license Lecanemab for the treatment of Alzheimer’s disease,” John Hardy, a neuroscientist at University College London, informed the 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 that we will now see wealthy people with early Alzheimer’s flying to the United States or other jurisdictions to receive treatment. I assume that this decision will be reviewed as US clinicians and others gather real-world data with lecanemab and donanemab.”

Tara Spiers-Jones, from the UK Institute for the Study of Dementia, stated: “The EMA’s decision will be a disappointment to 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, 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 enable communication between neurons. Every discovery brings us closer to new and better treatments.”

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