The FDA (agency that regulates and supervises food and medicine in the USA) granted this Thursday (6) full authorization for the use of the drug lecanemab, marketed as Leqembi, for the treatment of Alzheimer’s.
In January of this year, the agency had already released the use of the drug, aimed at reducing cognitive decline in patients who have not reached an advanced stage of the disease. At the time, it was highlighted that the drug also carries risks of swelling and bleeding in the brain.
The analysis of additional studies allowed, this Thursday, the expansion of access to the medicine in the United States.
Administered intravenously, Leqembi was developed by the Japanese pharmaceutical Eisai together with the American Biogen. Its price was set at US$ 26,500 (R$ 130,000) per year per patient.
The federal Medicare health insurance system, designed for people over 65, only covered the cost of the drug if it was administered in clinical trials, which limited access.
With full FDA authorization, it will be widely covered, said Chiquita Brooks-LaSure, director of the agency that administers Medicare.
“This is great news for the millions of people across the country living with this debilitating disease and their families,” she said.
Patients will still have to pay 20% of the cost of the drug, according to the FDA statement.
Teresa Buracchio, acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said the drug is the first to show clinical benefit against Alzheimer’s. One study, she added, confirmed the efficacy and safety of the treatment.
The research in question included 1,795 patients with early-stage Alzheimer’s. They were randomly divided into two groups.
Once every two weeks, members of one group were given the real drug, and those in the other were given a placebo (no effect) — they were unaware of which item they were consuming.
Overall, Leqembi had a positive effect on slowing the progression of the disease, according to the FDA. The survey result was validated by an advisory committee last month.
“People with the disease deserve to have the opportunity to discuss and decide, with their doctor and their family, whether the treatment is right for them,” said the president of the association of patients Alzheimer’s Association, Joanne Pike.
Leqembi’s label indicates that its use is restricted to patients in the early and mild stages of Alzheimer’s disease. It also instructs physicians not to treat them without doing tests to confirm whether they have one of the main characteristics of the disease: the accumulation of amyloid protein, the target of the drug.
It is estimated that about 1.5 million of the 6 million people with Alzheimer’s in the United States are in the early stages of the disease, diagnosed with mild or early-stage cognitive impairment.
Another cancer treatment developed by Esai and Biogen, Aduhelm, was the first to be approved by the FDA under an accelerated process. However, this decision was criticized by experts due to the lack of evidence on its effectiveness.
US pharmaceutical group Eli Lilly is also developing an Alzheimer’s treatment that targets amyloid plaques that has been shown to slow cognitive decline.
With AFP
