The Food and Drug Administration (FDA) has approved ansuvimab-zykl (Ebanga), a human monoclonal antibody, to treat Zaire ebolavirus (Ebolavirus) infection. Zaire ebolavirus is one of four ebolavirus species that can cause the potentially lethal Ebola disease in humans. Ebola can be transmitted through the blood or other body fluids of infected people and animals, as well as from contaminated surfaces (such as sheets or clothing). Ansuvimab-zykl prevents the virus from binding to the cell receptor and entering the cell.

Ansuvimab-zykl was evaluated in a clinical trial during the 2018-2019 Ebola outbreak in the Democratic Republic of the Congo. In the multicenter, open-label, randomized controlled trial, participants received one of four investigational drugs: ansuvimab-zykl, ZMapp (a triple monoclonal antibody), remdesivir (a nucleotide analogue RNA polymerase inhibitor), or a coformulated combination of three human IgG1 monoclonal antibodies.1 The primary efficacy endpoint was 28-day mortality.

A total of 681 patients with confirmed Ebolavirus infection were enrolled in the trial. Of these, 174 received ansuvimab-zykl, 169 received ZMapp, 175 received remdesivir, and 155 received the three-drug combination-all drugs were administered intravenously. After 28 days, fewer patients who received ansuvimab-zykl had died (35.1%) compared with those who received ZMapp (49.7%) or remdesivir (53.1). Even fewer patients receiving the three-drug combination died (33.5%). Based on these findings, ZMapp and remdesivir are now not used to treat Ebola.1 The three-drug combination (atoltivimab, maftivimab, and odesivimab) was approved as an Ebola treatment in October 2020 and is sold under the trade name Inmazeb.

Nurses working with patients receiving ansuvimab-zykl should monitor them for the drug's most common adverse effects: fever, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills, which are also common symptoms of Ebolavirus infection. Patients should also be monitored for hypersensitivity, including infusion-related events. Because ansuvimab-zykl may interact with the Ebola live virus vaccine and reduce its efficacy, this combination should be avoided.

To read the FDA news release regarding the approval of ansuvimab-zykl, go to http://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-treatment-ebo.

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