Eisai Alzheimer’s Drug Gets FDA Breakthrough Therapy Designation

(Bloomberg) -- Eisai Co. and Biogen Inc. said that the companies’ experimental Alzheimer’s drug lecanemab, now in late stage human trials, has received a breakthrough therapy designation from the U.S. Food and Drug Administration.

Lecanemab, also known as BAN2401, is the second drug the companies are working on that’s designed to remove amyloid from the brains of Alzheimer’s patients in an attempt to slow cognitive decline. The first -- the monoclonal antibody Aduhelm -- was approved by the FDA earlier this month for treating Alzheimer’s in one of the most controversial decisions in recent agency history.

The designation for lecanemab was based on promising data from a Phase 2 trial in patients with mild cognitive impairment or mild Alzheimer’s disease, the companies said in a statement. A Phase 3 study in 1,795 patients with early Alzheimer’s symptoms should be completed by the end of September 2022, according to the statement.

Breakthrough therapy status is designed to speed development and review of drugs for serious or life threatening ailments. It doesn’t mean the FDA will approve the drug in question, or that the agency has already determined that the experimental medicine is, in fact, a breakthrough.

Companies whose drugs receive the designation get additional guidance from the agency on the testing process, and are eligible for rolling and priority reviews of their FDA application should trials succeed.

In the fiscal year ended September 30, the FDA’s Center for Drug Evaluation and Research received 56 breakthrough therapy designation requests from companies, according to data posted on the FDA website. Through March 31, 2021, 17 of the requests had been granted, 19 had been denied, 6 requests were withdrawn, and the rest are pending.

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