The European Medicines Agency (EMA) has rejected approval in Europe for Leqembi (the brand name for lecanemab), an anti-Alzheimer’s drug approved a year and a half ago in the United States that slows cognitive decline by up to 27% in people with this type of dementia. The news has been met with cold water among neurologists and other groups, who consider the drug “safe” and hope it will be approved.
But the Pascal Maragall Foundation calls for calm and believes that this is “not a closed matter.” “Isaiah [la farmacèutica] He will provide new information and explain how this drug works this time in the United States. Not all drugs are approved the first time. “We are talking about complex diseases,” says the director of the foundation, Arkady Navarro.
The European Medicines Agency’s top health body issued a statement announcing its decision yesterday. It notes that after 18 months of treatment, comparisons between people who received the drug and those who received a placebo showed “small” differences. In addition, according to the European Medicines Agency’s Committee for Medicinal Products for Humans, “the observed effect of Lequimbe in delaying cognitive decline does not offset the risk of serious adverse events associated with the drug.”
“swelling and bleeding”
According to the European Medicines Agency, the “most significant safety concern” with Leqembi is “swelling and possible bleeding in the brain.” While it acknowledges that in most cases in the study these side effects “were not serious and did not involve symptoms,” it notes that “some patients experienced serious events, including major brain bleeding requiring hospitalization.”
“The seriousness of this side effect must be taken into account in the context of the mild effect observed with the medicine,” the European Medicines Agency said in a statement.
The European Medicines Agency notes that this risk is greater in people with two copies of the APOE4 gene, who are known to have a higher risk of developing Alzheimer’s disease and therefore “are likely to be eligible for treatment with Lequimbe”.
“In reaching its opinion, the Committee also took into account the views of a Scientific Advisory Group on Neurology, which included experts such as neurologists and people with the disease. Overall, it considers that the benefits of treatment are not important enough to outweigh the risks associated with Leqembi and therefore recommends refusing marketing authorisation in the EU.”
The news was received with “disappointment” in part of the medical community in Catalonia and in organizations such as the Ace Alzheimer’s Center. “We haven’t had a cure for Alzheimer’s since 2003. The first one came out in 1996. That is to say, to get here [al lecanemab] “It took us 30 years,” says neurologist Mercé Boada, medical director of the ACE Alzheimer’s Center in Barcelona, who regrets the EMA’s decision.
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