Alzheimer’s treatment used in US fails to convince EU authorities
Leqembi not granted official recommendation as chance of ‘bleeding on the brain’ is too great, says European Medicines agency
One expert professor said that the EMA’s decision would “be a disappointment for many”
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A treatment for Alzheimer’s that has been approved for use in North America has been recommended to be refused marketing authorisation in Europe, in a decision that has been dubbed “a major disappointment” for many.
The European Medicines Agency (EMA) issued its decision on the drug, sold under the brand name Leqembi (based on the molecule ‘lecanemab’), on July 26.
The drug has been in use in the United States since 2023 having been subject to accelerated approval by the U.S. Food and Drug Administration.
What is Leqembi?
Leqembi is thought to slow the progression of Alzheimer’s in its early stages by helping to prevent the development of amyloid plaques.
These plaques form in patients’ brains around neurons, which they eventually destroy, leading to memory loss.
A paper in the French science magazine Sciences et Avenir said that patients taking Leqembi appear to experience 27% less cognitive decline after 18 months of treatment, compared with a placebo.
The drug is administered intravenously once every fortnight.
Read more: Long-term health patients fear reimbursement reforms in France
‘Risk of severe side effects’
Despite the positive effects of the drug, the EMA said that it was concerned by the “risk of severe side effects” including “potential bleeding on the brain”.
“The proven but limited efficacy of the drug does not outweigh its potentially harmful consequences,” it said. “While the majority of patients suffered minor brain haemorrhages, others experienced serious effects, including major brain bleeds that required hospitalisation.”
The EMA only has the authority to issue ‘recommendations’ and ‘opinions’ on medicines, but the European Commission, which has the final say, does not usually go against its assessments.
Read also: Is there any support in France for English-speakers with Alzheimer’s?
‘Extreme disappointment’
Leqembi’s manufacturer, Japanese pharmaceutical company Eisai - which developed Leqembi in collaboration with American firm Biogen - said it was “extremely disappointed" with the EMA decision, and said it would request a “re-examination of the opinion”.
“This will be a disappointment for many,” said Professor Tara Spires-Jones, a specialist in neurodegeneration at the University of Edinburgh, Scotland, in a press release.
Bart De Strooper, professor at UCL University Hospital in London, said that the decision showed how medical approaches vary between countries and authorities.
“This result highlights a major cultural disparity in the way risk and innovation are perceived in different regions," he said. “Europe tends to see the glass as half empty, whereas countries like the United States, China and Japan see it as half full.”
In France, one expert said that the possible impact that Leqembi can have on the progression of the disease is “very significant”.
Bruno Dubois, Professor of Neurology and Director of the Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A) at the Pitié-Salpêtrière Hospital in Paris, said: “From a conceptual point of view, this is a very significant advance.”
However, he was also keen to point out that the medication does not ‘reverse’ or cure Alzheimer’s.
“The disease still gets worse, but less so than without medication,” he told La Dépêche. “Families and patients need to be aware of this to avoid disappointment.”
