The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

  • LOG IN
  • BECOME A MEMBER
  • About
    • Mission & Activities
    • Board of Directors
    • Staff & Volunteers
    • The Antibody Society’s Standing Committees
      • Communication & Membership Committee
      • Finance & Audit Committee
      • Initiatives Committee
      • Meetings Committee
    • Advisors
    • Sponsors
    • James S. Huston Antibody Science Talent Award
      • JSH Award Criteria
  • Society meetings
    • Antibody Engineering & Therapeutics (US) 2020
      • 2019 Antibody Engineering & Therapeutics
      • 2018 Antibody Engineering & Therapeutics
      • Meeting reports
      • Keynote presentations
      • What is INN a Name?
        • INN issue updates
    • Antibody Engineering & Therapeutics Europe 2020
      • Antibody Engineering & Therapeutics Europe 2019
    • AIRR Community Meetings
    • FOCIS Symposia
    • Society-Funded Meetings
  • AIRR Community
    • AIRR News
    • AIRR Publications
    • AIRR Meetings
      • AIRR Community Meeting VI: “Exploring New Frontiers”
      • AIRR Community Meeting V: “Zooming in to the AIRR Community”
      • AIRR Community Meeting V Pre-Meetings
        • AIRR-seq in the Pandemic
        • AIRR-seq Biological Standards and Workflows
      • AIRR Community Special Event: “Response to COVID-19”
      • AIRR Community Meeting IV: “Bridging the Gaps”
      • AIRR Community Meeting III
        • Day 1
        • Day 2
        • Day 3
        • Day 4
      • AIRR Community Meeting II
      • AIRR Community Meeting I
    • AIRR Community Working Groups
      • Biological Resources Working Group
      • Common Repository Working Group
      • Data Representation Working Group
      • Diagnostics Working Group
      • Germline Database Working Group
      • Legal and Ethics Working Group
      • Minimal Standards Working Group
      • Software Working Group
    • AIRR Community Sub-committees
      • Communications Sub-committee
      • Executive Sub-committee
      • Inferred Allele Review Committee
      • Meetings Sub-committee
    • AIRR Community Calendar
    • AIRR Community Resources
  • Members only
    • Login
    • Note to members
    • Antibodies in early-stage studies
    • Antibodies in late-stage studies
    • Presentations
  • Upcoming meetings
  • Web Resources
    • Society Publications
    • Antibody News You Should Know
    • Antibody therapeutics approved or in regulatory review in the EU or US
    • Research Resources
    • Education Resources
  • Career Center
  • Learning Center
    • Upcoming Webinars
    • Antibody Discovery & Development
    • Antibodies to Watch
    • Antibody Validation
  • COVID-19
    • Guide to “Coronavirus in the Crosshairs”
    • COVID-19 Biologics Tracker
    • Meeting Report: The Diagnostic Landscape for COVID-19
You are here: Home / Antibody therapeutic / FDA approves ansuvimab-zykl for Ebola virus infection

FDA approves ansuvimab-zykl for Ebola virus infection

December 21, 2020 by Janice Reichert

On December 21, 2020, the US Food and Drug Administration approved Ebanga (ansuvimab-zykl) for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga had been granted US Orphan Drug designation and Breakthrough Therapy designations. Ansuvimab is a human IgG1 monoclonal antibody that binds and neutralizes the virus.

The safety and efficacy of Ebanga were evaluated in the multi-center, open-label, randomized controlled PALM trial. In this study, 174 participants (120 adults and 54 pediatric patients) with confirmed Ebolavirus infection received Ebanga intravenously as a single 50 mg/kg infusion and 168 participants (135 adults and 33 pediatric patients) received an investigational control. The primary efficacy endpoint was 28-day mortality. Of the 174 patients who received Ebanga, 35.1% died after 28 days, compared to 49.4% of the 168 patients who received a control.

Ebanga is the 12th antibody therapeutic to be granted a first approval in the US or EU during 2020.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Filed Under: Antibody therapeutic, Approvals, Food and Drug Administration Tagged With: ansuvimab, antibody therapeutics, approved antibodies, Food and Drug Administration

Share this post

  • LinkedIn

Career Center

Our Career Center is a premier resource to connect highly qualified talent with matching career opportunities. Visit for details on over 800 jobs!

AIRR Community

AIRR Community

The Adaptive Immune Receptor Repertoire Community is a research-driven group organizing around the use of high-throughput sequencing technologies to study antibody/B-cell and T-cell receptor repertoires.

Recent Posts

  • Call for Papers on Biopharmaceutical Informatics January 19, 2021
  • Antibodies to Watch in 2021 is now online! January 19, 2021
  • Successful AIRR Community Meeting V January 15, 2021

Archives

Follow us online

  • Email
  • Facebook
  • LinkedIn
  • Twitter
  • Home
  • Privacy & Terms of Use
  • About
  • Board of Directors
  • Advisors
  • Sponsors
  • Mission & Activities
  • Join the Society
  • Membership Levels
  • Members only
  • Login
  • Antibody therapeutics approved or in regulatory review in the EU or US
  • Meeting reports
  • Presentations
  • Contact

©2015 - scicomvisuals