MRI image of the brain showing the area of a patient with Alzheimer’s.
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The Food and Drug Administration on Friday granted accelerated approval for Alzheimer’s disease drug lecanemab, developed by biogenic and the Japanese pharmaceutical company Eisai.
The FDA approval comes after clinical trial results released in November indicated that lecanemap somewhat slows cognitive decline in people with mild impairment due to Alzheimer’s disease, but the treatment also includes risk of brain swelling and bleeding.
Lecanemab will be marketed under the name Leqembi.
The agency can fast-track a drug’s approval to get it to market quickly if it’s expected to help patients with serious conditions more than is currently available. Biogen and Eisai, which developed the drug together, applied for accelerated approval in July.
“Alzheimer’s disease immeasurably cripples the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Billy Dunn, director of the FDA’s division of neuroscience, said in a statement. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s disease, rather than just treating the symptoms of the disease.”
The decision on lecanameb comes after Congress released a scathing report last week on how the FDA handled the controversial approval of another Alzheimer’s drug developed by Biogen and Eisai, called Aduhelm. The 2021 approval of this treatment, which experts said showed no clear clinical benefit, was “riddled with irregularities”, according to the report.
The Congressional report said the “FDA must take swift action to ensure that its processes for reviewing future treatments for Alzheimer’s disease do not lead to the same doubts about the integrity of the review of the FDA”.
Lecanemab is a monoclonal antibody that targets a protein called amyloid that accumulates in the brains of people with Alzheimer’s disease. The antibody is given intravenously every two weeks in doses determined by the patient’s body weight with 10 milligrams given per kilogram.
the results of clinical trials, published in the New England Journal of Medicine, found that cognitive decline was 27% slower over 18 months in people who received lecanemab compared to those who did not receive the treatment. The study was funded by Biogen and Eisai.
Cognitive decline was measured using a system called the Clinical Dementia Rating, which is an 18-point scale with a higher score indicating a higher level of impairment. It measures cognitive functions such as memory, judgment and problem solving.
Alzheimer’s disease progressed by an average of 1.21 points in the group that received lecanemab compared with 1.66 points in the group that did not receive the treatment, a modest difference of 0.45 points.
Nearly 1,800 people between the ages of 50 and 90 with early Alzheimer’s disease took part in the trial, about half of whom received lecanemab and the other half did not.
Security concerns
Although lecanemab may slow cognitive decline somewhat, the treatment also carries risks.
Almost 13% of those who received lecanemap developed brain swelling, compared to around 2% in the group who did not receive the treatment. However, most of these cases were mild to moderate in severity, did not cause symptoms, and usually resolved within four months.
About 3% of patients given lecanemab had more severe brain swelling with symptoms such as headaches, visual disturbances and confusion.
About 17% of those who received lecanemab had a brain hemorrhage, compared to 9% in the group who did not take the treatment. The most common symptoms associated with bleeding were dizziness.
Overall, 14% of people who received lecanemab experienced serious adverse events during the clinical trial, compared with 11% of those who did not receive the treatment.
The study authors said longer clinical trials are needed to determine the efficacy and safety of lecanemab in patients with early-stage Alzheimer’s disease.
The death of a clinical trial participant in the Chicago area could also be linked to lecanemap, according to a research letter published this week in the New England Journal of Medicine.
The 65-year-old suffered a stroke and was hospitalized four days after his third lecanemab infusion. A CT scan performed after the patient’s stroke revealed extensive bleeding in the brain. An MRI performed 81 days before the stroke found no bleeding.
The patient had also been given a drug, called t-PA, which is used to break up blood clots that cause strokes. But a large brain hemorrhage would be an unusual complication of this drug alone, according to the doctors who wrote the research letter.
Researchers involved in the lecanemap clinical trial, in a response letter, argued that the blood clot drug appeared to be the immediate cause of the patient’s death, with the first symptoms appearing 8 minutes after receiving an infusion of the anti- blood clots.
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