Today, Thursday, the US authorities expanded the scope of licensing the use of the new drug, “Leqembi” for Alzheimer’s disease, and circulated it after it was confined to a category of patients, by making it possible to obtain it in a more accessible way through the federal health insurance system.
In January, the US Food and Drug Administration authorized patients who had not yet reached advanced stages of the disease to use the new treatment, which slows cognitive decline.
The agency approved the drug under urgent procedures, but the analysis of additional studies made it possible to circulate permission to use the drug, according to the agency.
The Japanese drug group, Eisai, in cooperation with the American Biogen, innovated the new treatment, which is administered intravenously every two weeks.
Until now, Medicare, the federal health-coverage system for people over 65, did not cover the drug unless it was given in clinical trials, which greatly limited access.
Going forward, full authorization from the Food and Drug Administration will allow coverage of the drug “at scale.” “This is great news for the millions of people across the United States who are living with this debilitating disease for themselves and their families,” she added.
Leqembi
However, patients will still have to pay part of the cost from their own pockets (20 percent, or thousands of dollars), according to the statement.
The new drug, in which licanimab is the active ingredient, belongs to a new generation of drugs that target beta-amyloid deposits. Although the exact cause of Alzheimer’s disease is still unknown, patients’ brains develop amyloid plaques that form around neurons and damage them in the long run.
This causes patients to lose memory. In the advanced stages of the disease, patients become unable to carry out daily tasks or even hold conversations.
Liquimbi was the first drug shown to reduce cognitive decline in patients treated with it in clinical trials, by 27%.
However, the drug is accompanied by a warning that it can cause severe side effects, including cerebral hemorrhage or brain swelling that may lead to death.
“This drug, while not a cure-all, can help give people with it more time (…) to maintain their independence and do the things they love,” Joan Pike, president of the Alzheimer’s Association, said in a statement.
She added that people with the disease “deserve an opportunity to consult with their doctor and family and decide whether this medication is appropriate for them.”
Lequimbe is the second FDA-approved Alzheimer’s treatment recently, after Aduhelm, which was approved in June 2021, also developed by Esay and Biogen, and also targets amyloid plaques. Aduhelm was the first drug approved in the United States against the disease since 2003.
#America #expands #drug #Alzheimers
2023-07-07 20:18:22
