• 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
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » AiCuris’ Letermovir receives Fast Track designation

AiCuris’ Letermovir receives Fast Track designation

August 29, 2011
CenterWatch Staff

AiCuris announced today that the FDA has granted Fast Track designation for one of its lead drugs, AIC246, an inhibitor of the human cytomegalovirus (HCMV).

“Having obtained Orphan Drug status in the EU, receipt of Fast Track designation for Letermovir in the U.S. is another significant milestone for AiCuris" said Helga Rübsamen-Schaeff, CEO of AiCuris. “It will hopefully facilitate the regulatory process for this drug and supports our view that Letermovir has the potential to become the treatment of choice for patients at risk to develop severe and life-threatening HCMV disease, such as transplant recipients, newborns, patients in intensive care, certain cancer patients and HIV patients. These patients currently have only limited treatment options, due to the adverse side-effect profiles of existing drugs.”

Letermovir is currently being evaluated in an international phase IIb trial, which - based on the evaluation of an independent safety monitoring committee - has confirmed a positive safety profile. Results on efficacy from this trial are expected by the end of 2011. This data will demonstrate that Letermovir has no clinically significant drug-drug interactions when co-administered with immunosuppressive drugs.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

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

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

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 My Personal Information

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing