The United States has authorized the commercialization of a new medication for Alzheimer's disease. The FDA, the American drug agency, has recently recommended Leqembi, a promising new drug, for the treatment of early-stage Alzheimer's cases. What will be its cost, effectiveness, and side effects?
Despite the failure that followed the launch, a year and a half ago, of the first Alzheimer's medication, Aduhelm, composed of a different molecule, aducanumab, the avenue of immunotherapy for treating this neurodegenerative disease affecting more than 55 million people worldwide continued to be explored. Other molecules were tested until one of them finally proved itself. A few weeks ago, we were already discussing in these same columns, thanks to the valuable insights from Dr. Maï PANCHAL, PhD, General and Scientific Director of the Alzheimer's Defeat Foundation, the promising results of clinical trials conducted on lecanemab, a new molecule to combat Alzheimer's.
This same molecule, lecanemab, serves as the active ingredient in the new medication authorized in the United States and developed by the Japanese pharmaceutical company Eisai in collaboration with the American company Biogen. It did not take long for this promising molecule to enable the launch of a new treatment for Alzheimer's disease. In fact, part of the basis for FDA approval of Leqembi was derived from these clinical trials.
Recall that lecanemab, the active ingredient in Leqembi, is a monoclonal antibody belonging to immunotherapy, thus acting on the patient's immune system. In the case of this new medication, it is a form of passive immunotherapy in the form of an antibody administered directly intravenously. This antibody can bind to the protein that needs to be eliminated, the famous beta-amyloid protein implicated in Alzheimer's disease, allowing the brain to clear it. This represents a significant breakthrough because this treatment goes beyond merely addressing the symptoms, as its predecessors did, and aims to slow down the process of cognitive decline. During clinical trials, this medication has already shown a 27% slowing of cognitive decline in those who received it compared to the group that received a placebo.
Certain eligibility criteria will be considered for this new medication, namely the confirmation of Alzheimer's disease with the presence of amyloid plaques in the patient's brain and mild cognitive decline. According to FDA recommendations, this medication should be used for early forms of the disease to achieve real effectiveness. In a statement, Eisai estimated that about 100,000 people in the United States meeting these criteria could potentially receive Lequembi within three years.
While the introduction of Leqembi represents a significant advancement in the fight against Alzheimer's disease, some barriers still prevent it from being optimally accessible. While it will be launched at a much more reasonable price than Aduhelm, which faced criticism for its exorbitant cost of $56,000 per year, Leqembi will still cost $26,500 per year. The reimbursement modalities to be adopted by the federal healthcare coverage system, Medicare, have not yet been disclosed.
Regarding side effects, Dr. PANCHAL had already mentioned this concern during our interview on lecanemab's clinical trials: "Undesirable effects, often seen with the administration of anti-amyloid antibodies, known as ARIA (amyloid-related imaging abnormalities), have been observed. These ARIA manifest as cerebral edema or cerebral hemorrhages.
In total, 21.3% of patients treated with lecanemab developed ARIA, compared to 9.3% of patients who received the placebo. While these side effects are relatively rare, they can be serious. Therefore, it will be important to identify patients at risk of developing severe ARIA before administering the treatment. For example, it seems that patients on anticoagulants have a higher risk of developing cerebral hemorrhages with lecanemab, and individuals carrying the genetic risk factor for Alzheimer's disease, ApoE4, have a greater risk of developing symptomatic and severe ARIA with this treatment."
The scope of this promising new medication for early-stage Alzheimer's disease reminds us of the importance of diagnosing the disease as early as possible. Recent studies show that the disease is already present years before the onset of symptoms. Early diagnosis is a major focus of Alzheimer's research, which goes hand in hand with the discovery of new promising medications. While the patient care modalities with this new medication are yet to be defined, numerous hopes are finally being realized with its launch in the American market. Other molecules are currently under study, and progress is being made toward increasingly effective solutions to slow down Alzheimer's disease and perhaps one day succeed in combating it.
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