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The Food and Drug Administration on Friday approved Eisai and Biogen’s Alzheimer’s treatment lecanemab, clearing the way for the drug to be prescribed to patients and opening what will likely be a long debate over whether Medicare will pay for it.
The approval comes eighteen months after the FDA approved Eisai ESALY +4.10% (ticker: ESALY ) and Biogen BIIB +2.82% ‘s ( BIIB ) other Alzheimer’s drug Aduhelm. That drug has essentially been abandoned after Medicare chose not to cover it in virtually all instances.
Eisai said that lecanemab, which will be marketed under the name Leqembi, will be priced at $26,500 per year.
That’s close to the $28,200 per-year price point to which Biogen lowered Aduhelm in late 2021, after its initial price of $56,000 per year drew significant blowback. It’s slightly above the $8,500 to $20,600-per-year range that the influential drug pricing group the Institute for Clinical and Economic Review in December said would meet “traditional cost-effectiveness thresholds.”
“While we estimate the per-patient-per-year value of LEQEMBI treatment to the U.S. society to be $37,600, Eisai decided to price LEQEMBI below quantified societal value at the wholesale acquisition cost (WAC) of $26,500 per year,” the company said in a statement.
Aside from Aduhelm, Leqembi is the first Alzheimer’s treatment approved in roughly two decades, and the first-ever supported by convincing Phase 3 evidence of its clinical benefit.
The FDA approved Leqembi under its accelerated approval pathway, a route intended to allow the agency to approve promising treatments whose clinical benefit is not yet proven.
The FDA’s label for the new drug is far narrower than the label for Aduhelm, explicitly restricting the drug to early-stage Alzheimer’s disease patients. While Aduhelm’s label only said that the drug was indicated to treat Alzheimer’s disease, Leqembi’s says that it should be used “in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials,” and notes that no safety or effectiveness data is available for patients with earlier or later stages of the disease. Aduhelm’s label was criticized as overly broad, and as going beyond the evidence that the company had provided.
Biogen shares were up 6% on Friday afternoon, shortly after a trading halt lifted. The stock was up 3.6% before the halt. American Depositary Receipts of Eisai were up 11.1%.
Eisai said it would “work quickly” to request full approval from the FDA, using data from a Phase 3 trial that found Leqembi slowed cognitive decline in early-stage Alzheimer’s patients by 27% over 18 months. That data was not available when Eisai finalized its accelerated approval application.
The FDA said that its prescribing information for Leqembi includes a warning for the side effect known as amyloid-related imaging abnormalities, or ARIA, which can cause brain swelling and bleeding
The Food and Drug Administration on Friday approved Eisai and Biogen’s Alzheimer’s treatment lecanemab, clearing the way for the drug to be prescribed to patients and opening what will likely be a long debate over whether Medicare will pay for it.
The approval comes eighteen months after the FDA approved Eisai ESALY +4.10% (ticker: ESALY ) and Biogen BIIB +2.82% ‘s ( BIIB ) other Alzheimer’s drug Aduhelm. That drug has essentially been abandoned after Medicare chose not to cover it in virtually all instances.
Eisai said that lecanemab, which will be marketed under the name Leqembi, will be priced at $26,500 per year.
That’s close to the $28,200 per-year price point to which Biogen lowered Aduhelm in late 2021, after its initial price of $56,000 per year drew significant blowback. It’s slightly above the $8,500 to $20,600-per-year range that the influential drug pricing group the Institute for Clinical and Economic Review in December said would meet “traditional cost-effectiveness thresholds.”
“While we estimate the per-patient-per-year value of LEQEMBI treatment to the U.S. society to be $37,600, Eisai decided to price LEQEMBI below quantified societal value at the wholesale acquisition cost (WAC) of $26,500 per year,” the company said in a statement.
Aside from Aduhelm, Leqembi is the first Alzheimer’s treatment approved in roughly two decades, and the first-ever supported by convincing Phase 3 evidence of its clinical benefit.
The FDA approved Leqembi under its accelerated approval pathway, a route intended to allow the agency to approve promising treatments whose clinical benefit is not yet proven.
The FDA’s label for the new drug is far narrower than the label for Aduhelm, explicitly restricting the drug to early-stage Alzheimer’s disease patients. While Aduhelm’s label only said that the drug was indicated to treat Alzheimer’s disease, Leqembi’s says that it should be used “in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials,” and notes that no safety or effectiveness data is available for patients with earlier or later stages of the disease. Aduhelm’s label was criticized as overly broad, and as going beyond the evidence that the company had provided.
Biogen shares were up 6% on Friday afternoon, shortly after a trading halt lifted. The stock was up 3.6% before the halt. American Depositary Receipts of Eisai were up 11.1%.
Eisai said it would “work quickly” to request full approval from the FDA, using data from a Phase 3 trial that found Leqembi slowed cognitive decline in early-stage Alzheimer’s patients by 27% over 18 months. That data was not available when Eisai finalized its accelerated approval application.
The FDA said that its prescribing information for Leqembi includes a warning for the side effect known as amyloid-related imaging abnormalities, or ARIA, which can cause brain swelling and bleeding.