FDA Gives Full Approval to Alzheimer’s Drug Leqembi

The U.S. Food and Drug Administration recently gave full approval to the Alzheimer's drug Leqembi, clearing the way for insurance coverage of the pricey drug.

“The full FDA approval will open the floodgates for people with early Alzheimer's to get this drug. It's a big deal because it's very expensive at $26,500 per year," Robert Vassar, director of Northwestern Medicine's Mesulam Center for Cognitive Neurology and Alzheimer's Disease in Chicago, said in a statement released. "Now, Medicaid and Medicare will cover it as long as patients enroll in a registry to track their progress," he added.

“It's a big breakthrough because it's the first disease-modifying drug for Alzheimer's. This has been the holy grail since the early 1990s when amyloid was discovered, and people were trying to design drugs to eliminate amyloid from the brain," Vassar explained.

"This is the first successful one. There were many attempts in the past that failed. It really shows that removing amyloid does delay the progression of Alzheimer's disease," he said.

“During the 18-month trial,

Leqembi delayed the progression of Alzheimer's by five months, which is pretty significant," Vassar noted.

The approval did come with one significant caveat, however: The FDA added a so-called black-box warning to Leqembi's labeling, cautioning that in rare cases the medication can trigger "serious and life-threatening events," including brain bleeds, some of which have proven fatal.

Leqembi will only be available to people in the earliest stages of Alzheimer's — those with mild dementia or what's known as mild cognitive impairment. Labeling will also instruct physicians not to treat patients with Leqembi unless they have already undergone testing to confirm an uptick in levels of amyloid protein in their brain. Amyloid buildup is a key signal of Alzheimer's disease and Leqembi is designed to fight it.

Leqembi (lecanemab), which is made by Eisai Inc. and marketed by Biogen, will be only the second Alzheimer's drug to receive the FDA's blessing in the past two decades; the agency's accelerated approval of the drug Aduhelm in June 2021 generated controversy in the medical community over its lack of effectiveness, the concerns over brain bleeds and the drug's hefty price tag.