FDA decision to treat Biogen, Eisai with lekanemab

MRI image of the brain showing the area of ​​a patient with Alzheimer’s disease.

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The Food and Drug Administration on Friday granted fast-track approval for the Alzheimer’s drug lekanemab, the second treatment developed by Biogen and its Japanese partner Eisai, which received the green light two years later.

The FDA approval came after clinical trial results published in November showed that lecanemab somewhat slowed cognitive decline in people with mild Alzheimer’s impairment, but the treatment also came with a risk of brain swelling and bleeding.

Lekanemab will be marketed under the name Lekambi.

The agency may expedite approval of a drug to bring it to market quickly if it is expected to help patients suffering from serious illnesses to a greater extent than what is currently available. Biogen and Eisai, who developed the drug together, filed for fast track approval in July.

“Alzheimer’s disease immeasurably takes the lives of those who suffer from it and has a devastating impact on their loved ones,” Dr. Billy Dunn, director of the FDA’s division of neuroscience, said in a statement. “This treatment option is a novel therapy aimed at targeting the underlying process of Alzheimer’s disease, not just treating the symptoms of the disease.”

The decision on lekanameb comes after Congress released a scathing report last week about how the FDA handled a controversial approval of another Alzheimer’s drug developed by Biogen and Eisai called Aduhelm. The 2021 approval of this treatment, which experts say showed no clear clinical benefit, was “rife with irregularities,” according to the report.

The Congressional report states that “The FDA must take immediate action to ensure that its review processes for future treatments for Alzheimer’s disease do not lead to the same doubts about the integrity of the FDA’s review.”

Lecanemab is a monoclonal antibody that targets a protein called amyloid, which accumulates in the brains of people with Alzheimer’s disease. The antibody is administered intravenously every two weeks at doses determined by the patient’s body weight, at the rate of 10 milligrams per kilogram.

The FDA approved lecanemab based on the reduction in amyloid plaques seen in treated participants in clinical trials. The untreated participants in the placebo group had no reduction in amyloid plaques.

Results of clinical trials, published in the New England Journal of Medicinefound that cognitive decline occurred 27% slower over 18 months in people treated with lecanemab compared to those who did not receive treatment. The study was funded by Biogen and Eisai.

Cognitive decline was measured using a system called the dementia clinical score, which is an 18-point scale, where a higher score indicates a greater 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 lecanemab group compared to 1.66 points in the untreated group, a modest difference of 0.45 points.

The study involved nearly 1,800 people aged 50 to 90 with early-stage Alzheimer’s disease, about half of whom were receiving lecanemab and half were not.

Security Considerations

Although lecanemab may slow cognitive decline somewhat, treatment also comes with risks.

Nearly 13% of patients treated with lecanemab developed cerebral edema compared to about 2% in the untreated group. However, most of these cases were mild to moderate, did not cause symptoms, and usually resolved within four months.

About 3% of patients treated with lecanemab had more severe cerebral edema with symptoms such as headache, visual disturbances, and confusion.

Approximately 17% of patients treated with lecanemab had a cerebral hemorrhage, compared with 9% in the untreated group. The most common symptom associated with bleeding was dizziness.

Overall, 14% of people treated with lecanemab experienced serious side effects in clinical trials, compared with 11% of those who did not receive treatment.

The authors of the study stated that longer-term clinical trials are needed to determine the efficacy and safety of lekanemab in patients with early-stage Alzheimer’s disease.

The FDA said prescribing information for lekanemab will include a warning about the risk of edema and bleeding, which are broadly referred to as amyloid-related imaging abnormalities.

The death of a participant in a clinical trial in the Chicago area could also be related to lekanemab. research letter published in the New England Journal of Medicine this week.

A 65-year-old man suffered a stroke and was hospitalized four days after his third infusion of lekanemab. Computed tomography performed after the patient’s stroke revealed extensive cerebral hemorrhage. An MRI performed 81 days before the stroke showed no bleeding.

The patient also received a drug called t-PA, used to break up blood clots that cause strokes. But a massive cerebral hemorrhage would be an unusual complication of this drug alone, according to the doctors who wrote the research letter.

Investigators involved in the lekanemab clinical trial claimed in a response letter that the blood clot drug appeared to be the direct cause of the patient’s death, with the first symptoms occurring 8 minutes after they received an infusion of the drug to kill blood clots.

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