Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's.
The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class.
Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients.
Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies.
The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.
Persons:
Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis
Organizations:
U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson
Locations:
ANGELES, U.S, Los Angeles, Chicago