Explainer-Who is eligible for the new FDA-approved Alzheimer's drug?
By Deena Beasley
The U.S. Food and Drug Administration on Thursday granted standard approval to Eisai and Biogen (NASDAQ:BIIB)'s Leqembi for patients with Alzheimer's disease.
The FDA decision is expected to trigger broader coverage of the $26,500-a-year drug by the U.S. government's Medicare health plan for people aged 65 and older. Leqembi was granted «accelerated» FDA approval in January, but Medicare restricted coverage only to patients in clinical trials.
WHAT IS LEQEMBI?
Leqembi is an antibody designed to remove sticky deposits of a toxic protein called amyloid beta from the brains of Alzheimer's patients. The drug is administered every two weeks as an intravenous infusion.
Leqembi was shown in a pivotal trial to slow the rate of cognitive decline by 27% compared with a placebo after 18 months.
WHO WILL USE IT?
The FDA label for the drug says it should be started when patients are in the mild cognitive impairment or mild dementia stage of the degenerative brain disease.
The FDA recommends on Leqembi's label that doctors conduct testing for a gene called APOE4 that is associated with a higher risk of Alzheimer's as well as brain swelling associated with amyloid-lowering drugs. The FDA included a «boxed warning» that flags the risk of brain swelling on the label.
The agency does not require APOE4 genetic testing and doctors and patients will need to weigh the risk of brain swelling against the drug's potential benefits.
Around 25% of the population has one copy of the APOE4 gene, while up to 3% have two copies of the gene, according to the National Institute on Aging.
The FDA also warns that doctors should be particularly cautious when considering Leqembi for patients taking anticoagulants, which can also raise
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