FDA Advisers to Weigh Full Approval for Eisai-Biogen’s Alzheimer’s Drug

By Reuters
April 11, 2023US News
FDA Advisers to Weigh Full Approval for Eisai-Biogen’s Alzheimer’s Drug
The Alzheimer's drug Leqembi in an undated handout image obtained on Jan. 20, 2023. (Eisai/Handout via Reuters)

The 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.

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 percent compared with a placebo.

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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