Federal drug regulators on Friday approved lecanemab, sold under the brand name Leqembi, an Alzheimer’s drug that appears to slow the disease.
Participants received either a 10 mg per kilogram dose every two weeks over 18 months or a placebo.People on the drug were more likely to experience brain swelling and tiny bleeds compared to placebo.The decision to approve lecanemab came after last week's scathingIn an 18-month probe, investigators from two U.S. House committees reported the FDA sidestepped outside experts who said trials failed to prove clinical benefit of the drug, which was priced"unjustifiably high.
Marrwan Sabbagh, a neurologist and Alzheimer's researcher at Barrow Neurological Institute who analyzed the safety of lecanemab on behalf of Eisai, said most study participants did not report any symptoms. Those who did had headaches, visual disturbances and confusion, Sabbagh said. During the study, 13 people died – six people who were on lecanemab and seven who were on placebo. But some worry that people on blood thinners might be at risk for stroke or related event.
Eisai officials said they will promote sharing appropriate information so patients and families can make the best decisions.
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