The U.S. Food and Drug Administration on Friday approved Eisai Co Ltd and Biogen Inc's Alzheimer's drug lecanemab for the treatment of early forms of the fatal, brain-wasting disease.
Like their earlier Alzheimer's drug Aduhelm, lecanemab, to be sold under the brand name Leqembi, belongs to a class of treatments that aim to slow disease progression by removing sticky clumps of the toxic protein beta amyloid from the brain.Leqembi was approved for patients with Alzheimer's disease, and is recommended for use in people with mild cognitive impairment or early Alzheimer's - the same population in which the drug was tested.
The U.S. Centers for Medicare & Medicaid Services said Leqembi falls under its current policy severely limiting coverage of amyloid-lowering drugs to people enrolled in an approved clinical trial if the drug has gone through the FDA's accelerated approval process. "Given the data behind lecanemab, there is a case that Eisai can make for CMS reimbursement for the drug," said BMO analyst Evan Seigerman, adding that the drugmaker will need to negotiate with the agency.The drug comes with a requirement that patients undergo four MRI scans over the course of 14 weeks to check for signs of Amyloid Related Imaging Abnormalities or “ARIA," a type of temporary brain swelling that is frequently seen with drugs that remove amyloid from the brain.
The label urges doctors to be especially careful in giving the clot-busting stroke treatment known as a tissue plasminogen activator, or t-PA, to patients taking Leqembi, saying it can increase the risk of bleeding in the brain.
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