FDA Gives Full Approval to Alzheimer Disease Drug Leqembi

THURSDAY, July 6, 2023 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday gave full approval to the Alzheimer disease drug Leqembi (lecanemab-irmb), clearing the way for insurance coverage of the pricey drug.

"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," Teresa Buracchio, M.D., acting director of the Office of Neuroscience in the FDA Center for Drug Evaluation and Research, said in an agency news release. "This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer's disease."

The approval did come with one significant caveat, however: The FDA added a boxed 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. The agency also noted that the "prescribing information recommends caution when considering use of Leqembi in patients taking anticoagulants or with other risk factors for intracerebral hemorrhage."

Leqembi will only be available to people in the earliest stages of Alzheimer disease -- those with mild dementia or 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 disease, and Leqembi is designed to fight it.

The results of the original 18-month trial, which involved about 1,800 patients, gained wide attention when they were published last December in the New England Journal of Medicine. In the trial, early-stage Alzheimer disease patients who took Leqembi showed a 27 percent reduction in their mental decline compared with patients in the placebo arm of the trial. The drug's users also showed less evidence of amyloid protein plaques in their brain compared with nonusers.

Approval of Leqembi was granted to Eisai.

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