The European Medicines Agency (EMA) on Thursday approved for certain patients a long-awaited treatment intended to reduce cognitive decline in people suffering from Alzheimer’s disease, after initially blocking it in July.
The treatment, marketed under the name Leqembi, is now recommended by the EMA for patients who have not yet reached an advanced stage of the disease, the regulator said.
“After reviewing its initial opinion, the EMA Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization to Leqembi (lecanemab) for the treatment of mild cognitive impairment (speech disorders). memory and thinking) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease)”, and this for certain groups of patients, explained the EMA.
“A review concluded that the benefits outweigh the risks in a limited patient population,” she added.
The risk of side effects is linked to the patient’s genes. People who do not have a very specific gene, or who only have one copy of it, are less likely to have serious side effects than people who have two copies of that gene. In a new application, the drug manufacturer has therefore reduced the target group who can receive the drug to people with lower risk. However, this group concerns a large majority of patients.
In July, the EMA ruled against the marketing of Leqembi in the EU, finding that the observed effect of the treatment did not outweigh the risk of serious side effects, including potential bleeding in the brain and accumulation of fluids. In the most severe cases, these effects could be fatal.
Leqembi, developed by the Japanese pharmaceutical laboratory Eisai with the American manufacturer Biogen, was authorized in January 2023 in the United States for patients who had not reached an advanced stage of the disease. It is also marketed in Japan and China.
The British drug regulator approved this treatment last August.
Despite decades of research, scientists have so far failed to achieve a real breakthrough in the fight against Alzheimer’s disease, which affects tens of millions of people around the world.
The exact cause of this disease remains poorly understood. Observation of patients’ brains, however, shows the presence of amyloid plaques, which form around their neurons and ultimately destroy them.
This is what causes the memory loss characteristic of the disease. In the later stages, patients can no longer perform daily tasks or have conversations.
The Leqembi treatment, administered intravenously once every two weeks, allows, according to clinical trials, to reduce these amyloid plaques.
