federal agency food and drug regulator USAThe FDA has approved a highly anticipated new Alzheimer’s drug. The drug is known to be intended to reduce cognitive decline in patients who suffer from this disease neurodegenerative.
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The new treatment, which will be marketed by Eisai the pharmacist under the name of Leqembi, it is recommended by the FDA for patients who have not yet reached an advanced stage of the disease.
This drug represents “an important step in our battle to effectively treat Alzheimer’s disease”Which affects about 6.5 million Americansthe FDA said in a statement.
Leqembi, whose active substance is called lecanemab, attacks the deposits of a protein called beta-amyloid.
Although the cause of Alzheimer’s disease remains poorly understood, patients present with amyloid plaques in brainwhich form around neurons and eventually destroy them.
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This is what causes the characteristic memory leak of the illness.
The authorization of the FDA is based on the results of clinical trials that showed that the medicine helped reduce amyloid plaques.
Toothe agency mentions the results of larger clinical trials, recently published in a scientific journal.
These studiescarried out on almost 1,800 people who were followed for 18 months, revealed a reduction 27% in cognitive decline in patients treated with lecanemab.
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But the clinical trials also showed serious adverse effects: some of the patients treated They suffered brain hemorrhages.
In addition, at least one person who received the treatment died.
fda included a warning about the risk of bleeding in the drug information.
This is the second treatment for Alzheimer’s recently approved by the FDA, after the Aduhelm in June 2021 (which uses a molecule called aducanumab).
But the release of aduhelm did not have the expected success.
Its authorization unleashed controversy, given that some experts criticized the lack of evidence on its effectiveness.
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Later, its use was restricted to people with moderate cases. of the illness.
A recent report from the United States House of Representatives He also criticized the exorbitant price of the Aduhelm ($56,000 a year), and the federal health care system Medicare for the elderly announced that it will only reimburse it in clinical trials.