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Biogen’s Lecanemab shows less cognitive decline with Alzheimer’s, but more brain swelling


Amyloid plaques in Alzheimer's disease

Artur Plawgo

New data on Biogen (NASDAQ:BIIB) and Eisai’s (OTCPK:ESALY) (OTCPK:ESALF) Alzheimer’s lecanemab trial showed that although the biologic resulted in moderately less cognitive and functional impairment than placebo, it also associated with higher rates of brain swelling and bleeding.

The Phase 3 study of nearly 1800 patients with early-stage Alzheimer’s disease lasting 18 months concluded that longer trials are needed to determine the efficacy and safety of lecanemab.

The study, published in the journal New England Journal of Medicine, sponsored by two companies. FDA prepares to act on lecanemab by January 6.

Data show that based on the Clinical Dementia–Total Boxes Rating (CDR-SB), a scale of 18, people taking lecanemab showed an average cognitive decline of 1.21 points, compared with 1 .66 points for those taking a placebo. That’s a 27% difference.

For brain swelling, ~13% of lecanemab patients experienced brain swelling compared with 2% of patients receiving placebo. Swelling is considered mild to moderate. For brain bleeding, the numbers were 17% and 9%, respectively.

In addition, six deaths were reported in the lecanemab group and seven in the placebo group. However, the researchers said the deaths were not related to lecanemab or to swelling or bleeding in the brain.

On Monday, the magazine Science report a death related to lecanemab.

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