The European Medicines Agency on Thursday approved a long-awaited treatment aimed at slowing cognitive decline in people with Alzheimer's disease for certain groups of patients, after initially banning it in July.
The European regulator said the treatment, marketed under the name Leqembi, is now recommended by the European Medicines Agency for Alzheimer's patients who have not yet reached an advanced stage of the disease.
"Following a review of its preliminary opinion, the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended that marketing authorization be granted for Leqembi (lecanemab) for the treatment of mild cognitive impairment (disorders of speech, memory and thinking) or mild dementia due to Alzheimer's disease," for certain groups of patients, the EMA said in a statement.
"The review concluded that the benefits outweigh the risks in a limited number of patients," the statement added.
But the agency approved the treatment on Thursday only for patients at low risk of a possible brain haemorrhage, those who have "only one or no copy of the ApoE4 gene - a type of gene known to be an important risk factor for Alzheimer's disease".
The Amsterdam-based European Medicines Agency said these patients are less likely to suffer from certain serious health problems than people with two copies of the gene.
The drug "Lekembi", developed by Japanese pharmaceutical company Eisai and US manufacturer Biogen, was licensed in January 2023 in the United States for patients who have not reached an advanced stage of the disease. It is also marketed in Japan and China.
The British medicine regulator approved the treatment last August.
Despite decades of research, scientists have so far failed to make a real breakthrough in the fight against Alzheimer's disease, which affects tens of millions of people around the world.
The exact cause of the disease is also still poorly understood. However, monitoring the patients' brains shows the presence of amyloid plaques, which form around nerve cells and eventually destroy them.
This causes the memory loss that affects Alzheimer's patients. In the later stages, patients are no longer able to perform daily tasks or communicate.
According to clinical trials, Lekimbi, which is given intravenously once every two weeks, can reduce amyloid plaques.
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