• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA grants Fast Track Designation to E2609 for Alzheimer's

FDA grants Fast Track Designation to E2609 for Alzheimer's

November 18, 2016
CenterWatch Staff

Eisai announced has received FDA Fast Track designation for the development of E2609, a Beta-secretase Cleaving Enzyme (BACE) inhibitor currently being evaluated in phase III clinical trials for early Alzheimer's disease. E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen as a potential Alzheimer's disease (AD) modifying treatment.

The FDA's Fast Track program is intended to facilitate the development and review of new therapies to treat serious conditions and tackle key unmet medical needs by allowing for frequent interactions with FDA. It may also enable priority review by FDA if supported by clinical data at the time of NDA submission.

"We are excited that the FDA has granted Fast Track designation to E2609," said Lynn Kramer, M.D., chief clinical officer and chief medical officer, Neurology Business Group, Eisai. "We look forward to working closely with the FDA to expedite this clinical program and hope to offer an important treatment option for patients who suffer from early Alzheimer's disease."

Discovered in-house by Eisai, E2609 is an investigational next-generation oral candidate for the treatment of AD that inhibits BACE, a key enzyme in the production of amyloid beta (Aβ) peptides. By inhibiting BACE, E2609 may decrease the formation of toxic Aβ peptide aggregates and amyloid plaques in the brain, thereby potentially slowing disease progression. The first phase III study for E2609 in the clinical trial program called MISSIONAD began in October 2016 and will enroll 1,330 patients with biomarkers confirmed for early Alzheimer's disease.

This release discusses an investigational agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that this investigational agent will successfully complete clinical development or gain FDA approval.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing