It marks the first-ever approval of a drug proven to moderately slow the course of Alzheimer's disease.
The FDA said the approval was based on clinical trial data that showed Leqembi, from drugmakers Eisai and Biogen, slows cognitive decline by about 27 percent compared to a placebo among Alzheimer's patients who are in the early stages of the disease.
But the agency also added a black box warning to the label, a nod to the concerns over serious side effects. The FDA said that in rare cases the drug can cause "serious and life-threatening events" and that there have been cases of brain bleeding, "some of which have been fatal."
"Today's action is the first verification that a drug targeting the underlying disease process of Alzheimer's disease has shown clinical benefit in this devastating disease," said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research.
The agency's decision also triggers a change in how the Medicare program will cover the twice-a-month infusion, which costs $26,500 annually.
The Centers for Medicare and Medicaid Services (CMS) currently limits coverage to people who are participating in clinical trials, but full FDA approval means Medicare will broaden coverage for potentially millions more, even as Leqembi's benefits and risks remain a source of debate.
About 6.7 million people in the U.S. are diagnosed with Alzheimer's, and that number is expected to rise as the population ages. There are about 1.5 million patients in early stages of Alzheimer's disease.
Still, drugmaker Eisai has said it expects only about 100,000 patients will be eligible and using the drug in its first three years on the market.
"With FDA's decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works. This is welcome news for the millions of people in this country and their families who are affected by this debilitating disease," CMS Administrator Chiquita Brooks-LaSure said in a statement.
As part of its coverage decision, Medicare will require providers to collect data for patient registries about how the drug performs in real-world settings, something patient advocates decried as a barrier. CMS has indicated it's trying to make registry participation as easy as possible for clinicians and patients.
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