Healthcare Purchasing News
  • Magazine
  • Continuing Education
  • Webinars
  • Whitepapers
  • Videos
  • Events
  • Hall of Fame
  • Advertise
  • Source Guide
  • Subscribe
  • Sourcing & Logistics
  • Sterile Processing
  • Surgical & Critical Care
  • Patient Satisfaction
  • Infection Prevention
  • EVS & Facility Services
  • Healthcare IT
  • Regulatory
  • Topics
    Sourcing & LogisticsSterile ProcessingSurgical & Critical CarePatient SatisfactionInfection PreventionEVS & Facility ServicesHealthcare ITRegulatory
    Resources
    HPN Source GuideContinuing EducationWebinarsWhitepapersVideosEventsHall of FameAdvertiseAd Specs
    User Tools
    SubscribeContact UsAbout UseNewsletterMagazinesPrivacy PolicyTerms & Conditions
    https://www.facebook.com/hpnonline
    https://www.linkedin.com/company/healthcare-purchasing-news/
    https://twitter.com/HPN_Online
    1. Infection Prevention

    FDA approves new use of transplant drug based on real-world evidence

    July 19, 2021
    Image by Gerd Altmann from Pixabay
    FDA approves new use of transplant drug based on real-world evidence

    The U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. FDA approved Prograf for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation. 

    Prograf, originally approved to prevent organ rejection in patients receiving liver transplants, was later approved to prevent organ rejection for kidney and heart transplants as well. The drug has also been routinely used in clinical practice for patients receiving lung transplants. Today’s action marks the first approval of an immunosuppressant drug to prevent rejection in adults and pediatric patients who receive lung transplants. Prograf is the only approved immunosuppressant drug product for this population. 

    This approval reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data (RWD), when compared with a suitable control, can be considered adequate and well-controlled under FDA regulations. Specifically, the non-interventional study supporting approval for this new indication used RWD from the U.S. Scientific Registry of Transplant Recipients (SRTR), supported by the Department of Health and Human Services.

    The data were collected on all lung transplants in the U.S. and were supplemented by information from the Social Security Administration’s Death Master File as a trusted repository of mortality data. A dramatic improvement in outcomes was observed among lung transplant patients receiving Prograf as part of their immunosuppression medications compared to the well-documented natural history of a transplanted drug with no or minimal immunosuppressive therapy.  

    In addition to the RWE from the non-interventional study, randomized controlled trials of Prograf used in other solid organ transplant settings provided confirmatory evidence of effectiveness. Additional clinical trial evidence from research publications supports the independent contribution of Prograf as part of a multidrug immunosuppressive regimen.  

    Prograf should only be prescribed by physicians experienced in immunosuppressive therapy and management of organ transplant and patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Prograf is associated with increased risk of developing lymphoma and other malignancies and is associated with increased susceptibility to bacterial, viral, fungal, and protozoal, including opportunistic infections.

    FDA granted the approval to Astellas Pharma US, Inc.

    FDA release

    More COVID-19 coverage HERE.

    Latest in Infection Prevention

    Photo 117616099 | Antimicrobial Resistance © Designer491 | Dreamstime.com
    Infection Prevention

    IDSA announces Antimicrobial Stewardship Centers of Excellence designation recipients

    Janette Wider
    Nov. 21, 2023
    Photo 32161147 © Fasphotographic | Dreamstime.com
    Infection Prevention

    Global measles threat continues to grow as another year passes with millions of children unvaccinated

    Nov. 21, 2023
    Photo 281959520 © Zelwanka | Dreamstime.com
    Infection Prevention

    Expedited availability of additional doses of new RSV immunization for infants

    Nov. 20, 2023
    Photo 175971946 © Adonis1969 | Dreamstime.com
    Infection Prevention

    WHO releases updated guidelines on treatments for COVID-19

    Nov. 16, 2023
    Photo 124874066 © Marian Vejcik | Dreamstime.com
    Infection Prevention

    FDA approves vaccine to prevent disease caused by chikungunya virus

    Nov. 14, 2023
    Healthcare Purchasing News
    https://www.facebook.com/hpnonline
    https://www.linkedin.com/company/healthcare-purchasing-news/
    https://twitter.com/HPN_Online
    • About Us
    • Contact Us
    • Advertise
    • Do Not Sell or Share
    • Privacy Policy
    • Terms & Conditions
    © 2023 Endeavor Business Media, LLC. All rights reserved.
    Endeavor Business Media Logo