The Food and Drug Administration granted accelerated approval for Eisai and Biogen’s experimental Alzheimer’s drug, lecanemab, on Friday, offering a new treatment option for the more than 6.5 million people with Alzheimer’s disease in the United States.
Lecanemab, which targets a type of plaque in the brain made up of the protein beta-amyloid that is believed to cause memory and cognitive problems, showed promising results in slowing the rate of cognitive decline among patients in the early stages of Alzheimer’s in a Phase 3 trial, potentially setting it up to garner millions in revenue once it hits the market.
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“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Dr. Billy Dunn, the director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”
Trial results showed that lecanemab reduced cognitive and functional decline by 27% in the test group, compared to those on a placebo treatment, over 18 months among nearly 1,800 participants in the early stages of Alzheimer’s.
The drug has been one of first to have success in slowing the progression of the disease that has no known cure, but reports of serious adverse events with trial patients, including brain swelling and bleeding, had raised some questions about its safety.
Eisai told the Washington Examiner in November that available safety data suggest that the drug is not associated with an “increased risk of death overall or from any specific cause.”
The FDA said lecanemab, which will be sold under the name Leqembi, should be started in patients with “mild cognitive impairment or mild dementia stage of disease.” The most common side effects are infusion-related reactions, headache, and amyloid-related imaging abnormalities, also known as ARIA, which usually do not have symptoms but could lead to some rare serious and life-threatening events.
Patient advocacy groups in wake of the decision have requested that the Centers for Medicare & Medicaid Services revise its current policy, which limits coverage of a class of Alzheimer’s drugs to patients enrolled in clinical trials or approved studies.
“While this news is exciting, without insurance and Medicare coverage of this class of treatments, access will be limited to only those who can afford to pay out-of-pocket. The Alzheimer’s Association has submitted a formal request asking CMS to remove the requirement that Medicare beneficiaries be enrolled in a clinical trial in order to receive coverage of FDA-approved Alzheimer’s treatments,” said Joanne Pike, the president and CEO of the Alzheimer’s Association.
The FDA and Biogen had received increased scrutiny leading up to the decision after a recent report from House Democrats faulted the FDA’s accelerated approval process for Biogen’s controversial Alzheimer’s drug, Aduhelm, and Biogen’s hefty price tag.
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Aduhelm was the first therapy for the disease to receive approval in nearly two decades in 2021, but it has since faced challenges on the market as Medicare significantly limited coverage of the drug amid concerns over its effectiveness. Though Biogen’s initial price tag of $56,000 annually was cut in half before, Medicare’s decision has limited its affordability for many patients.
