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Brussels: The European Commission He said on Wednesday that she granted official approval to LeqembiA long -awaited new treatment for Alzheimer’s disease in the early stage, to be sold in the European Union under strict circumstances.
The mandate was granted on Tuesday based on a positive decision by drug control in Europe, which after the initial concerns provided treatment last November to a specific group of patients.
LeQEmbi, which was developed by the United States multinationals BIOGEN EISAI in Japanese is the brand name of an active material called LECANMAB that is used to treat adults with light memory and cognitive problems caused by the early stages of the common type of dementia.
The first such drug is allowed in the European Union. The drug was approved in line with “positive scientific evaluation of European Pharmaceutical AgencyThe committee said in a statement.
the Ema The committee said, “The benefits of this medicine outperformed the risks, in a certain group of patients who suffer from this disease and as long as the measures of risk reduction are applied,” the committee said.
“Therefore, the delegation decision puts strict conditions on the use of LeQEmbi, as well as the requirements of clear mitigation to mitigate the risk,” he said.
EMA supported the drug only for patients with a risk of decreased in potential brain bleeding: those who have only one copy or no copy of APOE4 “, a type of genes known as an important risk factor for Alzheimer’s disease.
LECANEMAB was welcomed by researchers and charities in Alzheimer’s disease, as it is the first approved treatment to treat the early stages of the disease, rather than symptoms management.
It works using antibodies that are associated with proteins that are usually associated with the brains of people with Alzheimer’s disease, which is the most common type of dementia.
Treatment has been proven to reduce cognitive decrease in a quarter of a quarter of the early stages of the disease.
LeQEmbi, with someone else Alzheimer’s disease Aduhelle received the arrival of approval from the US Food and Drug Administration in 2023.
