Eisai: FDA confirms enough data to move Alzheimer's drug to Phase III studies

TOKYO – Japan's Eisai Co said on Tuesday the U.S. Food and Drug Administration had confirmed that there was sufficient data to start Phase III studies of a drug it is co-developing to treat early Alzheimer's disease.

The investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 was discovered by Eisai and is being jointly developed with Massachusetts-based Biogen Inc, Eisai said in a statement.

Following the discussion with the FDA on the Phase III clinical study designs, Eisai and Biogen plan to have similar discussions with regulatory authorities in Japan and the European Union, Eisai said.