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Home » Directories » FDA Approved Drugs » Ebanga (ansuvimab-zykl)

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Ebanga (ansuvimab-zykl)

  • Profile

Profile

Contact Information

Contact: Ridgeback Biotherapeutics
Website: http://www.ebanga.com/

Currently Enrolling Trials

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    General Information

    Ebanga is a human monoclonal antibody. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell.

    Ebanga is specifically indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients (including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection).

    Ebanga is supplied as single injection in a lyophilized form.

    Mechanism of Action

    Ebanga is a human monoclonal antibody isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, a city in the DRC. Nancy Sullivan, Ph.D., Chief of the Biodefense Research Section at the NIAID, VRC and her team, alongside scientists from VIR Biotechnology’s Humabs BioMed S.A. subsidiary, discovered that the survivor retained antibodies against Ebola 11 years after infection. The team isolated the antibodies, tested the most favorable ones in both laboratory and nonhuman primate studies, and selected ansuvimab as the most promising among the set for clinical trial.. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell.

    Side Effects

    Adverse effects associated with the use of Ebanga may include, but are not limited to, the following:

    • fever
    • tachycardia
    • diarrhea
    • vomiting
    • hypotension
    • tachypnea
    • chills

    Clinical Trial Results

    Ebanga was evaluated in a clinical trial (the PALM trial) during the course of an Ebola outbreak in the Democratic Republic of the Congo (DRC) in 2018-2019. The PALM trial was led by the U.S. National Institutes of Health and the DRC’s Institut National de Recherche Biomédicale with contributions from several other international organizations and agencies.

    In the PALM trial, the safety and efficacy of Ebanga was evaluated in a multi-center, open-label, randomized controlled trial. 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. The primary analysis population was all patients who were randomized and concurrently eligible to receive either Ebanga or the investigational control during the same time period of the trial. 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.

    Approval Date: 2020-12-01
    Company Name: Ridgeback Biotherapeutics
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