6/23, 10:35 PM (Source: TeleTrader)
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FDA grants special status for Biogen, Eisai Alzheimer treatment

Biogen Inc. and Eisai Co., Ltd. announced on Wednesday that the United States Food and Drug Administration (FDA) gave their lecanemab antibody treatment for Alzheimer’s disease the designation of Breakthrough Therapy.

The designation indicates that the FDA plans to accelerate the development and the review of the treatment, as well as "more intensive guidance" on the drug itself. Additionally, this would make lecanemab eligible for a rolling review or even a priority review, when it comes to that stage.

According to the statement, the designation was granted due to the successful Phase 2b clinical trial and the ongoing Phase 3 trial, but the company's were careful to note that there is "no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval."

Breaking the News / OL