The FDA approved ansuvimab-zykl (Ebanga; Ridgeback Biotherapeutics) for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children.
Officials with the FDA have approved ansuvimab-zykl (Ebanga; Ridgeback Biotherapeutics) for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children, according to a press release.
Ansuvimab-zykl is the second treatment to receive FDA approval for the treatment of Ebola virus. A monoclonal antibody mixture composed of atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb; Regeneron) was approved in October 2020.
Ansuvimab-zykl, a human monoclonal antibody, was evaluated in the PALM clinical trial amid the Ebola outbreak in the Democratic Republic of the Congo in 2018-2019.
In the multi-center, open-label, randomized controlled PALM study, 174 patients (120 adults and 54 pediatric patients) with confirmed Ebola virus infection received ansuvimab-zykl intravenously as a single 50 mg/kg infusion, and 168 participants (135 adults and 33 pediatric patients) received an investigational control. Of those patients who received ansuvimab-zykl, 35.1% died after 28 days, compared with 49.4% of the patients who received a control therapy.
The most commonly reported adverse effects (AEs) in the trial include fever, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills; however, these are also common symptoms of the Ebola virus infection, according to the FDA.
According to the FDA, patients who receive ansuvimab-zykl should avoid the concurrent administration of a live virus vaccine against Ebola virus, as there is a potential for the drug to inhibit replication of a live vaccine virus and possibly reduce the efficacy of the vaccine.