FDA grants fast-track approval for Alzheimer’s drug Leqembi: Shots

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US health authorities have approved a new Alzheimer’s drug, Leqembi, that slightly slows brain disease. On Friday, the FDA granted accelerated approval for patients with early-stage Alzheimer’s disease.

David Duprey/AP

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David Duprey/AP


US health authorities have approved a new Alzheimer’s drug, Leqembi, that slightly slows brain disease. On Friday, the FDA granted accelerated approval for patients with early-stage Alzheimer’s disease.

David Duprey/AP

The Food and Drug Administration has approved a drug to help people with early stages of Alzheimer’s disease maintain their mental abilities.

Lecanemab, marketed as Leqembi, is expected to reach far more patients in 2021 than the similar product Aduhelm, which failed after a controversial approval.

“This is an important step for people who are eligible for this treatment, their families, and the research community,” said Maria Carrillo, director of research at the Alzheimer’s Association.

But Leqembi, like Aduhelm, can cause swelling or bleeding in the brain, which means patients should have periodic brain scans after starting treatment. It’s also unclear whether Medicare and private health insurers will cover the drug, which costs tens of thousands of dollars each year.

Eisai, the company that developed Leqembi in partnership with another drugmaker, Biogen, said the treatment costs $26,500 a year.

A new drug, given intravenously every two weeks, removes a substance called amyloid from the brain. Sticky amyloid plaques are a hallmark of Alzheimer’s disease, but many previous drugs that target amyloid have failed to slow patients’ cognitive decline.

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