Early this year, the FDA approved Alzheimer’s treatment drug Leqembi (lecanemab-irmb) using its Accelerated Approval pathway.
Accelerated Approval provides a path under which the FDA can approve drugs for serious conditions after demonstrating an unmet medical need. To earn approval, the drug must be shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. Additionally, the results of a Phase 3 randomized, controlled clinical trial to confirm the drug’s benefit must have recently been reported.
According to the FDA, Leqembi targets beta-amyloid plaque build-up in the brains of patients in the mild cognitive impairment or mild dementia stages of Alzheimer’s disease.
“The unquestionably positive data from the clinical studies of Leqembi indicate that thorough removal of beta-amyloid from the brain leads to clinical benefit,” said Maria C. Carrillo, Ph.D., chief science officer with the Alzheimer’s Association. “This treatment can change the course of Alzheimer’s in a meaningful way for people in the early stages of the disease, allowing more time to participate in daily life and live independently.”
The Centers for Medicare & Medicaid Services currently limits coverage of drugs that target amyloid in the brain. Without additional coverage, Leqembi, which must be administered biweekly, will cost around $25,000 annually for a single patient.
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