US authorizes long-awaited new treatment for Alzheimer's disease
The brain contains billions of neurons. Alzheimer's is characterized by the presence of two types of proteins (beta-amyloid or tau) that prevent the transfer of signals between these nerve cells.
US health authorities on Friday authorized a new Alzheimer's drug aimed at reducing cognitive decline in patients suffering from this neurodegenerative disease. It is a long-awaited treatment after the failed launch of a previous drug with a similar mechanism a year and a half ago.
The new treatment, which will be marketed as Leqembi, is now recommended by the United States Medicines Agency (FDA) for patients who have not yet reached an advanced stage of the disease.
Administered intravenously once every two weeks, it is designed by the Japanese pharmaceutical company Eisai, in partnership with the American Biogen.
It represents an important step forward in our battle to effectively treat Alzheimer's disease, which affects some 6.5 million Americans, the FDA said in a statement. communicated.
Leqembi, whose active ingredient is called lecanemab, targets deposits of a protein called beta-amyloid. While the exact cause of Alzheimer's disease remains poorly understood, patients' brains show amyloid plaques that form around their neurons and eventually destroy them.
This is what causes the memory loss characteristic of the disease. In the later stages, patients can no longer carry out daily tasks or hold conversations.
The FDA clearance is based on clinical trial results that showed the drug helped reduce amyloid plaques.
The agency also cites the results of larger clinical trials, recently published in a scientific journal, for which the FDA expects to receive full data soon.
Conducted on nearly 1,800 people followed for 18 months, these trials revealed a 27% reduction in cognitive decline in patients treated with lecanemab. This is a first for a drug of this type.
But the study also revealed serious side effects: some of the patients treated suffered from cerebral hemorrhages. At least one person who received the treatment has died.
Given these concerns, whether lecanemab will truly be a game-changer as some say remains unproven, experts wrote in the scientific journal The Lancet in early December.
The FDA has included a warning about the risk of bleeding in the drug information. According to a statement from Eisai, approximately 100,000 people could receive this treatment in the United States within three years, given the eligibility criteria (mild cognitive impairment and confirmation of the presence of amyloid plaques). ).
Biogen Pharmaceuticals is located in Cambridge, Massachusetts.
This is the second Alzheimer's treatment recently approved by the FDA, following Aduhelm in June 2021 (which uses a molecule called aducanumab). Also produced by the companies Biogen and Eisai, and also targeting amyloid plaques, Aduhelm was the first drug brought to market against this disease in nearly two decades.
But its launch was not as successful as expected: its authorization sparked controversy, with some experts criticizing the lack of evidence on its effectiveness. Its use was later restricted to people with moderate cases of the disease.
A recent US parliamentary report also blamed its exorbitant price tag ($56,000 per year). The federal health insurance system Medicare, intended for the elderly, had announced that it would only reimburse it if it was taken within the framework of clinical trials.
Leqembi will be launched at a price of $26,500 per year, with the aim of promoting access for patients, reducing the overall financial burden and supporting the sustainability of the health system, Eisai announced on Friday in a statement.
The issue of Medicare coverage for this new treatment has not yet been decided.
People living with this deadly disease don't have time to wait for a miracle cure, Joanne Pike, president of the Alzheimer's Association, said in a statement. , who called for Medicare to agree to reimburse Leqembi.
It has been approved under an accelerated FDA program, which allows faster approval of treatments for serious pathologies that cannot be effectively cared for.
For decades, researchers have failed to achieve a real breakthrough in the fight against Alzheimer's disease, and that's why the The clearance of this new class of treatments has raised so much hope among some. However, no remedy allowing a cure still exists to this day.