The Food and Drug Administration granted full approval to a costly new Alzheimer’s drug today, clearing the way for Medicare and many private insurance plans to start covering the treatment for people with the brain-destroying disease.
It approved drug Leqembi for patients with mild dementia and other symptoms of early Alzheimer’s disease. It is the first medicine that has been persuasively shown to modestly slow the cognitive decline caused by Alzheimer’s.
Japanese drugmaker Eisai received conditional approval from the FDA six months ago based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.
The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared with those who got a placebo.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” says FDA neurology drug director, Dr. Teresa Buracchio.
FDA drug approval processes typically occur without publicity. But Alzheimer’s patients and advocacy groups have been lobbying the FDA to approve it for months, after federal officials announced in early 2022 that they wouldn’t pay for routine use of drugs like Leqembi until they receive the FDA’s full approval.
They worried that the cost of new plaque-targeting Alzheimer’s drugs could overwhelm the finances of Medicare, which pays for medical care for 60 million older people. Leqembi costs a whopping $26,500 for a year’s supply of IVs, which are administered every two weeks. The approval of Leqembi is likely to increase Medicare costs by billions and billions of dollars annually.
Most Americans with Alzheimers are covered by Medicare. Private insurers have been following Medicare’s lead in withholding coverage for Leqembi and a similar drug, Aduhelm, until they receive the FDA’s full endorsement. It is likely to take years before the FDA finishes it approval process for Aduhelm.
