MRI image of the brain showing the realm of a patient with Alzheimer’s disease.
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The Food and Drug Administration on Friday granted accelerated approval for the Alzheimer’s drug drug lecanemab, the second treatment from Biogen and her Japanese partner Eisai will receive an early green light in lower than two years.
The FDA approval comes after clinical trial results published in November showed that druganemab somewhat slows cognitive decline in people with mild impairment brought on by Alzheimer’s disease, however the treatment also carries a risk of brain swelling and bleeding.
Eisai, which led to the event of lekanemab, he values the treatment at $26,500 per yr within the USA It can be sold under the name Leqembi.
The FDA may speed up approval of a drug to get it to market quickly if it is anticipated to assist patients affected by serious conditions greater than what’s currently available. Biogen and Eisai applied for accelerated approval in July.
“Alzheimer’s disease greatly impairs the lives of those that suffer from it and has a devastating impact on their family members,” Dr. Billy Dunn, director of the FDA’s neuroscience division, said in an announcement. “This treatment option is the most recent therapy to focus on and address the underlying disease technique of Alzheimer’s disease, not only the symptoms of the disease.”
Over 6.5 million people in america suffer from Alzheimer’s disease. Irreversible disease destroys memory, the power to think, and ultimately the power to perform easy tasks.
The choice on lecanameb comes after Congress issued a scathing report last week on how the FDA handled the controversial approval of one other Alzheimer’s drug developed by Biogen and Eisai called Aduhelm. The 2021 approval of this treatment, which experts say showed no clear clinical profit, was “ridden with irregularities” in response to the report.
The Congressional report stated that “the FDA must act quickly to be sure that its review processes for future treatments for Alzheimer’s disease don’t result in the identical doubts concerning the integrity of the FDA’s review.”
Moderately slows down the disease
Lekanemab is a monoclonal antibody directed against a protein called amyloid that builds up within the brain of individuals with Alzheimer’s disease. The antibody is given intravenously every two weeks in doses based on the patient’s weight, 10 milligrams per kilogram.
In keeping with the agency’s statement, the FDA approved druganemab based on the reduction in amyloid plaque observed in clinical trial participants who received the treatment. Participants who received no treatment, the placebo arm, had no reduction in amyloid plaque.
Clinical trial results, published within the Latest England Journal of Medicinefound that cognitive decline was 27% slower over 18 months in individuals who received druganemab in comparison with those that didn’t receive 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 the next rating indicating greater levels of impairment. It measures cognitive functions resembling memory, judgment and problem solving.
Alzheimer’s disease progression averaged 1.21 points within the drug-treated group compared with 1.66 points within the group that received no treatment, a modest difference of 0.45 points.
The study involved nearly 1,800 people aged 50 to 90 with early-onset Alzheimer’s disease, about half of whom were receiving lekanemab and half weren’t.
Safety considerations
While lekanemab may slow cognitive decline somewhat, treatment also carries risks.
Nearly 13% of those that received druganemab developed cerebral edema compared with around 2% within the group who didn’t receive treatment. Nevertheless, most of those cases were mild to moderate in severity, asymptomatic, and typically resolved inside 4 months.
Around 3% of patients receiving druganemab experienced more severe brain swelling with symptoms including headache, visual disturbances and confusion.
Around 17% of those that received druganemab had a bleeding within the brain, compared with 9% within the group that didn’t receive treatment. Essentially the most common bleeding-related symptoms were dizziness.
Overall, within the clinical trial, 14% of those that received druganemab experienced serious adversarial events, compared with 11% of those that didn’t receive treatment.
The authors of the study said longer clinical trials are needed to find out the efficacy and safety of lekanemab in patients with early-onset Alzheimer’s disease.
The FDA said that drug prescribing information will include a warning concerning the risk of swelling and bleeding, broadly known as amyloid-associated imaging abnormalities.
The death of a clinical trial participant within the Chicago area can also be linked to lecanemab, in response to a scientific letter published within the Latest England Journal of Medicine this week.
The 65-year-old suffered a stroke and was hospitalized 4 days after his third infusion of lekanemab. A CT scan performed after the patient’s stroke showed extensive bleeding within the brain. An MRI performed 81 days before the stroke showed no bleeding.
The patient was also given a medication called t-PA, which is used to interrupt up blood clots that cause strokes. In keeping with the doctors who wrote the research letter, extensive brain bleeding could be an unusual complication of this drug alone.
Investigators involved within the lekanemab clinical trial argued in a response letter that the anticoagulant seemed to be the immediate explanation for the patient’s death, with the primary symptoms occurring 8 minutes after receiving the anticoagulant infusion.