USFDA advisers to weigh full nod for Eisai-Biogen Alzheimer's drug Leqembi

Leqembi belongs to a class of treatments that aim to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.

Published On 2023-04-11 04:30 GMT   |   Update On 2023-04-11 12:16 GMT
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US: The U.S. Food and Drug Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer's drug developed by Eisai Co Ltd and Biogen Inc, according to a federal filing on Monday.

The drug, Leqembi was granted accelerated approval by the FDA in January for patients in the earliest stages of the mind-wasting disease.

The U.S. health regulator grants the so-called accelerated approval based on data that show therapies are likely to work, and requires confirmatory trials later to give them full approval.

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In the large trial of Leqembi, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer's by 27% compared with a placebo.

Read also: Eisai-Biogen Alzheimer's drug Lecanemab should be priced below Aduhelm: Report

The FDA's independent advisers, who are scheduled to meet on June 9, will discuss the data from the study.

Leqembi belongs to a class of treatments that aim to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.


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Article Source : Reuters

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