2023-07-08 12:16:20
On Thursday, the US authorities expanded the scope of licensing the use of the new drug, “Leqembi” for Alzheimer’s disease, and circulated it following 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.
And already to the US Food and Drug Administration In January, the FDA approved the use of a new treatment that slows cognitive decline for patients who are not yet in advanced stages of the disease.
The agency approved the two drugs 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 pharmaceutical group, Eisai, in cooperation with the American Biogen, innovated the new treatment, which is administered intravenously every two weeks.
The drug was not yet covered by Medicare, the federal health coverage system for people over 65, unless it was given in clinical trials, which greatly limited access to it.
The head of the agency that administers Medicare, Chiquita Brooks Lashore, said in a statement that full authorization from the Food and Drug Administration would henceforth allow coverage of the drug “at scale.”
“This is good news for the millions of people across the United States who are living with this debilitating disease and for their families,” she added.
However, patients will still have to pay 20% of the cost out of their pockets, i.e. thousands of dollars, according to the statement.
The way the medicine works
The new drug, in which licanimab is the active ingredient, belongs to a new generation of drugs that target amyloid beta deposits. Although the exact cause of Alzheimer’s disease is still unknown, the brains of patients show amyloid plaques that form around nerve cells and destroy 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,” said Joan Pike, president of the Alzheimer’s Association, in a statement.
She added that people with the disease “deserve the opportunity to consult with their doctor and their families and decide whether this medicine is appropriate for them.”
Liquimbe is the second FDA-approved treatment for Alzheimer’s disease recently, following Aduhelm, which was approved in June 2021. It was also developed by Esay and Biogen and targets amyloid plaques as well. Aduhelm was the first drug approved in the United States once morest the disease since 2003.
However, this treatment caused a great controversy, as the US Medicines Agency opposed the opinion of an expert committee, which considered that the treatment had not proven sufficiently effective during clinical trials. The agency later restricted its use to people with mild cases of the disease.
The US pharmaceutical company Eli Lilly is also working on a drug that has shown to slow down cognitive decline by 35% in Alzheimer’s patients with high beta-amyloid and low tau protein.
For decades, researchers have failed to make real progress in fighting Alzheimer’s disease, so some see the new Lekembe as promising. No other cure for Alzheimer’s has yet to be found.
1688946018
#authorities #expand #authorization #drug #slows #deterioration #Alzheimers #patients #health
