US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
Jan 26, 2025

(Reuters) - The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen (NASDAQ: BIIB )'s Alzheimer's drug Leqembi, the companies said on Monday.

The drug received standard U.S. approval in 2023 after showing it slowed cognitive decline in patients with the brain-wasting disease but growth has been slow, in part because its administration is time-consuming and it requires regular MRIs and screenings.

Patients can switch to a monthly dose after having received an intravenous infusion of the drug every two weeks for 18 months, the companies said in a joint statement. They can also continue to dose once every two weeks.

Leqembi clears sticky deposits of a protein called amyloid beta in the brain, believed to be a hallmark of Alzheimer's disease. Patients receive the drug at an infusion center in almost an hour-long process.

The companies said that modeling simulations of trial data predicted that maintenance dosing would maintain benefits of the therapy.

A rival drug from Eli Lilly (NYSE: LLY ), Kisunla, was approved in July and is given by infusion once a month. Patients stop taking the treatment once brain scans no longer show amyloid plaques.

US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug

Both drugs have safety warnings regarding the potential for brain swelling and bleeds. Patients are recommended to undergo monitoring with scans.

Eisai has a collaboration agreement with BioArctic on the drug.