The U.S. Food and Drug Administration approved the intravenous (IV) treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. It is one of four Ebolavirus species that can cause a potentially fatal human disease.
Privately-held, majority woman owned biotechnology company Ridgeback Biotherapeutics’ Ebanga (Ansuvimab-zykl), a human monoclonal antibody in the form of IV infusion drug, has been approved based on the results of the PALM clinical trial.
The trial was conducted during an Ebola outbreak in the Democratic Republic of the Congo (DRC) in 2018-2019. The virus is transmitted through blood, body fluids, and tissues of infected people or wild animals, and through surfaces and materials, such as bedding and clothing, contaminated with these fluids.
The individuals under highest risk for the virus infection are those who care for people with the disease, including health care workers who do not use correct infection control precautions.
The safety and efficacy of Ebanga was evaluated in a multi-center, open-label, randomized controlled PALM trial, which enrolled a total of 342 participants (255 adults and 87 pediatric patients) with confirmed Ebolavirus infection.
Out of these, 174 patients (120 adults and 54 pediatric patients) 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 percent died after 28 days, compared to 49.4 percent of the 168 patients who received a control.
For the treatment of Ebolavirus, Ebanga received an orphan drug designation, which provides incentives to assist and encourage drug development for rare diseases. Additionally, the application was granted breakthrough therapy designation by the FDA.
The FDA warned that patients who receive Ebanga should avoid the concurrent administration of a live virus vaccine against Ebolavirus as there is the potential for Ebanga to inhibit replication of a live vaccine virus and possibly reduce the efficacy of this vaccine.
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