The US Food and Drug Administration has approved antibody Ebanga for the treatment of the Ebolavirus infection (Zaire ebolavirus) in adults and children, 44 years after the deadly disease was first discovered.
Zaire ebolavirus is one of four Ebolavirus species that can cause a potentially fatal human disease. It 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.
Ebanga, human monoclonal antibody, blocks binding of the virus to the cell receptor, preventing its entry into the cell.
During an Ebola outbreak in the Democratic Republic of the Congo in 2018-2019, Ebanga was evaluated in a clinical trial, called the PALM trial, which was led by the US 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, and 168 participants (135 adults and 33 pediatric patients) received an investigational control.
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.
The most common symptoms experienced while receiving Ebanga include: fever, diarrhea, vomiting, low blood pressure and chills. However, these are also common symptoms of Ebolavirus infection.
Patients who receive Ebanga have been advised to avoid the concurrent administration of a live virus vaccine against Ebolavirus. There is the potential for Ebanga to inhibit replication of a live vaccine virus and possibly reduce the efficacy of this vaccine.
Ebanga was granted an Orphan Drug designation, which provides incentives to assist and encourage drug development for rare diseases.
Additionally, the agency granted Ebanga a Breakthrough Therapy designation, a process designed to expedite the development and review of drugs that are intended to treat a serious condition.