First Ebola Treatment Approved By the US FDA
Written By: Paphapin Pairojtanachai
October 19, 2020
Back in December, the US Food and Drug Administration (FDA) approved Ervebo, the first vaccine for the Ebola virus disease. This vaccine acts as a prevention from acquiring the disease after an individual is infected by the Zaire ebolavirus, but there was no treatment for those who have already been diagnosed with the disease until only four days ago. The first FDA-approved treatment for the Ebola virus infection is called Inmazeb, also known as antibody cocktail REGN-EB3, since it is a mixture of three monoclonal antibodies — man-made antibodies that are designed to mimic the ones that the body produces naturally during an infection — atoltivimab, maftivimab, and odesivimab-ebgn. This intravenous drug was developed by Regeneron Pharmaceuticals with the same “rapid response” techniques for the investigational antibody combination for COVID-19.
The Zaire ebolavirus is transmitted through direct contact with body fluids, blood, or other tissues of infected individuals. It can also be transmitted through surfaces or materials that are contaminated with these body fluids. By binding to the receptor of the host cell and fusing with the cell membrane, the Ebola virus is able to enter the cell. The three antibodies that comprise Inmazeb inhibit this process by simultaneously attaching to the glycoproteins on the surface of the virus, thus blocking infection, and by mobilizing immune cells to clear out the virus as well as infected cells.
In the Pamoja Tulinde Maisha (PALM) Trial, or “Together Save Lives”, during the second largest Ebola outbreak in the Democratic Republic of the Congo (DRC) in 2018, Regeneron partnered with the World Health Organization (WHO), the US FDA, the National Institutes of Health (NIH), and the DRC’s Institut National de Recherche Biomédicale (INRB) to test the Inmazeb treatment. The clinical trial involved a total of 681 adult and pediatric patients who were divided into two groups. The first group was administered with 50 mg of each of the three antibodies composing Inmazeb, while the other group served as a control. Within the group that received Inmazeb, 33.8% died after a period of 28 days, in contrast to the 51% who died among the control group.
Although approved by the FDA, it should be noted that there may be some adverse reactions following injection of the drug. Some side effects experienced by the clinical subjects of the PALM trial include fever, chills, rapid heartbeat and breathing, low blood pressure, vomiting, diarrhea, and insufficient oxygen supply to tissues. In addition, in the case of severe hypersensitivity reactions or problems related to infusion of the drug, the rate at which Inmazeb is infused into the bloodstream should be slowed or disrupted.
Today, Regeneron is continuing to provide Inmazeb for free to treat Ebola patients in the DRC. With the FDA’s approval, it will be easier for local doctors and public health agencies to access the national stockpiles of Inmazeb in the US and use them in affected areas.
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