US health authorities on Thursday fully authorized a new treatment for Alzheimer’s, making it more accessible through the federal health insurance system.
Leqembi, which aims to reduce cognitive decline, is authorized for patients who have not yet reached an advanced stage of the disease.
It had been approved in January by the American Medicines Agency (FDA) according to an accelerated procedure. Analysis of additional studies has now allowed full clearance, the FDA said in a statement.
Administered intravenously every two weeks, it is developed by the Japanese pharmaceutical company Eisai with the American Biogen. Its price was set at $26,500 per year per patient.
The federal Medicare health coverage system, intended for people over 65, has so far only covered it if it was taken in the context of clinical trials, de facto greatly limiting its access.
With full FDA clearance, it will now be “broadly” covered, Chiquita Brooks-LaSure, head of the Medicare governing body, said in a statement. “This is good news for the millions of people across the country living with this debilitating disease, and their families. »
However, patients will still have to pay part of the cost out of pocket (20%, or several thousand dollars), the statement said.
Leqembi is part of a new generation of treatments targeting a protein called beta-amyloid, which forms plaques in the brains of sick patients.
“To date, Leqembi is only approved in the United States. It is being evaluated by regulatory agencies, particularly in Europe, Japan, the United Kingdom and China,” Emmanuel Roux, director of market access at Eisai France, told AFP on Friday.
This drug was the first to clearly demonstrate a reduction in cognitive decline (by 27%) in a clinical trial. Without treating patients, it can help slow the progression of the disease a little.
However, it comes with a warning: it can cause serious side effects, such as edema or cerebral hemorrhage, which can be fatal.
“This treatment, although not a cure, can help give people more time […] to maintain their independence and do the things they love,” said Joanne Pike, president of the Alzheimer Association.
People with the disease “deserve the opportunity to discuss and decide, with their doctor and their family, if this treatment is right for them”, she added.
Another treatment developed by Eisai and Biogen against Alzheimer’s, Aduhelm, was the first to be authorized by the FDA under an accelerated procedure. But this decision had been widely criticized by experts in the face of the lack of evidence on its effectiveness.
The American pharmaceutical group Eli Lilly is also developing a treatment against Alzheimer’s targeting amyloid plaques and having demonstrated a reduction in cognitive decline. In the spring, the company announced that it wanted to quickly file authorization requests worldwide.