On July 6, 2023, the US Food and Drug Administration (FDA) fully approved a new drug for Alzheimer’s patients.
In January 2023, the FDA issued a provisional approval for the use of the substance lekanemab-irmb (market name Leqembi) through the so-called fast track route. The Agency uses this procedure in particularly justified cases, for example, when there is an unmet need for health in the community. So what does the institution’s decision yesterday mean for patients? Check.
New Alzheimer’s drug targets the cause of the disease, not its symptoms
Full FDA approval for a drug means greater drug availability for patients and a lower cost burden for therapy. Some of these will be covered by health insurance. The drug contains antibodies that reduce the number of beta-amyloid (Aβ) plaques. So they do not affect the symptoms, but the cause of the disease.
It is worth recalling that in Alzheimer’s disease, pathological proteins (consisting of beta-amyloid and tau protein) accumulate in the brain, which leads to premature death of nerve cells. As a result, we are dealing with a decrease in the number of neurons and serious disturbances in the functioning of the nervous system. The patient has difficulty concentrating, remembering and retrieving information, and regulating emotions. Over time, he loses all the skills that he acquired during his life, and cannot function normally.
The efficacy of the drug was evaluated in a randomized clinical trial involving 1795 patients with Alzheimer’s disease. Treatment was started in patients with mild cognitive impairment or mild dementia and confirmed presence of pathological protein structures in the nervous system. The patients were divided into groups. One received a placebo and the other received 10 milligrams (per kilogram) every two weeks. The use of the drug significantly slowed down the progression of pathological changes in the brain (compared to placebo).
FDA warns of side effects of Alzheimer’s drugs
As the US Food and Drug Administration warns, taking an approved drug for the treatment of Alzheimer’s disease carries the risk of unwanted side effects in the form of headaches and dizziness, confusion, visual disturbances, nausea and vomiting. There may also be alarming symptoms from the nervous system, including convulsions, as well as life-threatening cerebral edema and intracerebral hemorrhage. The drug is not recommended for use in patients using anticoagulants who are allergic to any of the ingredients of the drug, as well as in those who have an increased risk of hemorrhage in the midbrain.
Source: Food and Drug Administration.
Source: Wprost
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