• 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 approves Viread for children with HIV-I

FDA approves Viread for children with HIV-I

January 20, 2012
CenterWatch Staff

The FDA has approved Gilead Sciences’ Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-I infection in pediatric patients ages 2 to 12.

Originally approved in 2001 for individuals aged 18+, and then again in 2010 for individuals ages 12 to 17, Viread is now approved for patients aged 2 to 12, with dosage based on age and weight. The safety and efficacy of Viread has not been established in children less than two years of age.

The FDA approved a supplemental New Drug Application (sNDA) for three lower-strength, once-daily tablets of Viread in doses of 150mg, 200mg and 250mg for children ages 6 to 12. The agency also approved an NDA for an oral powder formulation of Viread for children ages 2 to 5. The active ingredient in Viread, tenofovir disoproxil fumarate, is currently the most-prescribed molecule for adults receiving HIV therapy in the United States.

The pediatric regulatory applications for Viread were supported by clinical data from a phase III safety and efficacy study of a Viread-containing antiretroviral regimen compared to an antiretroviral regimen containing zidovudine or stavudine in HIV-infected treatment-experienced children ages 2 to 12. The safety profile observed in the study was consistent with that observed in clinical trials in adults. The applications were submitted to the FDA on July 18, 2011.

Although prenatal interventions have sharply decreased the number of U.S. children born with HIV, there remains an “unmet need for heat-stable, taste-neutral pediatric formulations that do not require cold storage, particularly in resource-limited settings, where mother-to-child transmission remains a significant challenge,” said Norbert Bischofberger, Ph.D., executive vice president, R&D and chief scientific officer for Gilead Sciences. “We are very pleased to provide an important new therapeutic option for younger HIV patients, and will work to make the pediatric formulations of Viread available as quickly as possible.”

In an effort to accelerate the availability of pediatric formulations in low-income countries, in July 2011 Gilead announced new incentives to encourage its Indian generic manufacturing partners to develop pediatric formulations of its HIV medicines.

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

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

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