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Alzheimer’s Drug Maker Expects FDA Approval This Summer

FDA approval would expand Medicare coverage for the $26,500/year drug, but rollout could take years.

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According to a recent CNBC article, Japanese drugmaker Eisai expects the FDA to fully approve its Alzheimer's treatment Leqembi this summer. Leqembi, which was developed with Biogen, is an expensive new antibody that has shown promise in slowing the progression of Alzheimer's disease in people over the age of 65.  The company estimates that 100,000 people are expected to receive an early Alzheimer's diagnosis and become eligible for Leqembi by 2026, though the number of undiagnosed people is almost certainly higher.

Eisai has priced Leqembi at $26,500 per year, and the Centers for Medicare & Medicaid Services will determine how broadly it is covered for patients diagnosed with early Alzheimer's. Medicare published guidance in April 2022 that limits coverage for Alzheimer's drugs like Leqembi that use antibody treatments to target the plaque linked to the cause of 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, making the medication out of reach for most patients, except the very wealthy.

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