Eisai announced that the Food and Drug Administration (FDA) has granted Fast Track designation for E2609 (Eisai and Biogen) in development for early Alzheimer’s disease

E2609 is an investigational oral beta-secretase cleaving enzyme (BACE) inhibitor that is currently being evaluated in Phase 3 clinical trials. BACE is a key enzyme in the production of amyloid beta peptides. Its inhibition may reduce the formation of toxic amyloid beta peptide aggregates and amyloid plaques in the brain, potentially slowing disease progression.  

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The first Phase 3 study for E2609 under the MISSIONAD clinical program started in October 2016 and will enroll 1,330 patients with biomarkers confirmed for early Alzheimer’s disease. 

The Fast Track program helps the development and review of new treatments for serious conditions and addresses key unmet needs by allowing for frequent interactions with the FDA. 

For more information call (888) 422-4743 or visit Eisai.com.