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Japanese drugmaker Eisai expects the Food and Drug Administration to fully approve its Alzheimer’s treatment Leqembi this summer, which would expand access to the pricey new antibody under Medicare.
U.S. CEO Ivan Cheung said the FDA, which granted accelerated clearance in January, could give full approval as soon as July if the company gets an expedited “priority review” for demonstrating a significant improvement in how early Alzheimer’s is treated.
“We’re literally talking about maybe like five months away, so we are moving with urgency definitely with CMS right now,” Cheung told CNBC in an interview Thursday. The Centers for Medicare and Medicaid Services is the federal agency that will determine how broadly Leqembi, which Eisai has priced at $26,500 a year, is covered for patients diagnosed with early Alzheimer’s.
The company, which developed the drug with Biogen, estimates 100,000 people are expected to receive an early Alzheimer’s diagnosis and become eligible for Leqembi by 2026 though though the number of undiagnosed people is almost certainly higher.
The Alzheimer’s Association estimates that more than 2,000 people aged 65 and older progress from mild to moderate dementia due to the disease per day, making them ineligible for Leqembi.
Early Alzheimer’s typically hits people ages 65 and older, causing cognitive impairment and other issues. Leqembi has shown promise in slowing the disease’s progression in that population, but it carries risks of brain swelling and bleeding.
Medicare published guidance in April 2022 that limits coverage for Alzheimer’s drugs like Leqembi that use antibody treatments to target the plaque that causes the disease. Under Eisai’s current accelerated approval status, Medicare will only cover the costs of people in clinical trials approved by the FDA or National Institutes of Health.
Eisai has completed its phase three trial and is no longer enrolling patients. This…
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