Treatment for Ebola Virus Approved by FDA
An Orphan Drug Designation was granted to Ridgeback Biotherapeutics, LP, creator the therapy.
Ebanga, a human monoclonal antibody that treats Zaire ebolavirus (Ebolavirus), has been approved by the U.S. Food and Drug Administration for use in adults and children. The therapy blocks the binding of the virus to the cell receptor which prevents it from entering into the cell.
Zaire ebolavirus, which is one of four Ebolavirus species, is transmitted through bodily fluids like blood, materials contaminated with such fluids, as well as the tissue of wild animals or infected individuals and can be a potentially fatal disease. Healthcare workers and others who look after people infected with the virus are at a high risk of infection if the correct precautions are not taken.
Ebanga was evaluated in a clinical trial, called the PALM trial, that was led by the U.S. National Institutes of Health and the Institut National de Recherche Biomédicale, including many other international organizations and agencies during an Ebola outbreak in the Democratic Republic of the Congo in 2018-2019.
During the multi-center, open-label, randomized controlled trial, Ebanga was evaluated for its levels of safety and efficacy. The primary efficacy endpoint was 28-day mortality. The trial included 342 participants, of which 174 who had a confirmed case of an Ebolavirus infection received a single intravenous dose of 50 mg/kg of the therapy, while 168 participants received an investigational control. 35.1% of those who received the treatment died after 28 days, compared to 49.4% in the control arm.
The most common symptoms reported by participants who received the medicine were also common symptoms of the Ebolavirus itself, these included fever, chills, diarrhea, vomiting, tachycardia, hypotension and tachypnea. There were also records of hypersensitivity, like infusion-related events, occurring in the patients.
Those who plan on receiving Ebanga to treat an Ebolavirus infection should make sure to avoid a coinciding administration of a live virus vaccine, due to the potential for the therapy to impede on the replication of a live virus, which can potentially weaken the vaccines efficacy.