The US Food and Drug Administration has approved monthly maintenance dosing of Leqembi, an Alzheimer’s disease drug developed by Japan’s Eisai and its partner Biogen, the two companies announced Monday.
The drug received standard U.S. approval in 2023 after showing it slowed cognitive decline in patients with the brain disease, but growth has been slow, in part because it takes time to administer and that it requires regular MRIs and screenings.
Patients can move to a monthly dose after receiving an intravenous infusion of the drug every two weeks for 18 months, the companies said in a joint statement. They can also continue to receive a dose every two weeks.
Leqembi removes sticky deposits of a protein called beta-amyloid in the brain, considered a hallmark of Alzheimer’s disease. Patients receive the medication at an infusion center in a procedure that lasts nearly an hour.
The companies said modeling simulations of the trial’s data predicted that maintenance dosing would maintain the therapy’s benefits.
-A competing drug from Eli Lilly, Kisunla, was approved in July and is administered by infusion once a month. Patients stop treatment when brain scans no longer reveal the presence of amyloid plaques.
Both drugs come with safety warnings about the risk of brain swelling and bleeding. Patients are recommended to undergo CT monitoring.
Eisai has entered into a collaboration agreement with BioArctic for this drug.
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