FDA Grants Traditional Approval To Eisai's Leqembi To Treat Adult Patients With Alzheimer's Disease

(RTTNews) - The U.S. Food and Drug Administration granted a traditional approval to Eisai Co., Ltd. (ESALY.PK, ESALF.PK) and Biogen Inc.'s (BIIB) Leqembi (lecanemab-irmb) to treat adult patients with Alzheimer's Disease.

Leqembi was approved in January under the Accelerated Approval pathway.

Eisai noted Thursday that the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease.

The company advised that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

The most common side effects of Leqembi were headache, infusion-related reactions and amyloid-related imaging abnormalities (ARIA), a side effect known to occur with the class of antibodies targeting amyloid.

Alzheimer's disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. The disease slowly destroys memory and thinking skills and eventually, the ability to carry out simple tasks.

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