On Tuesday, the Food and Drug Administration issued the first-ever approval for therapy against the Ebola virus.
Although the Ebola vaccine, Ervebo, was approved late last year and proved to be 97.5% effective in preliminary studies, the newly approved therapy may be useful in tackling the ongoing outbreak in the Democratic Republic of Congo, which began in June. FDA approval may also increase the prospects for similar therapies developed for COVID-19 that may become available prior to vaccination.
The newly approved Ebola treatment, called Inmazeb (also known as REGN-EB3), is a combination of three monoclonal antibodies made by Regeneron Pharmaceuticals. The antibodies target the only protein on the outside of the Ebola virus particles – the glycoprotein. Ebola uses its glycoprotein to attach to and enter human cells, causing infection. The antibody cocktail targets the protein, preventing it from invading the cells.
In a 2018-2019 clinical trial amid an Ebola outbreak in the North Kivu and Ituri provinces of the DRC, Inmazeb outperformed three other treatments being tested side by side. Of the 154 Ebola patients who received Inmazeb, 33.8% died after 28 days, compared with 51% of 153 patients who received a different experimental antibody. Untreated, Ebola has an average mortality rate of about 50 percent, although mortality rates can vary greatly between outbreaks, from 25 percent to 90 percent.
Ebola has caused 11 outbreaks since it was first identified in the DRC in 1976.you The outbreak began on June 1 this year in the Mbandaka region of Equatorial Province and continues. So far, more than 100 people have been infected, causing at least 47 deaths. The 10syou The outbreak, which began on August 1, 2018 in the province of North Kivu, was declared to end on June 25, 2020, after the outbreak infected 3470 people, killing 2287 (65% mortality). The largest reported outbreak of Ebola was the 2014 outbreak in West Africa, resulting in more than 28,000 cases and 11,000 deaths.
“We are incredibly proud that the FDA has approved Inmazeb,” George Jankopoulos, president and chief scientific officer of Regeneron, said in a press release. He noted that Ebola “has caused a number of deadly outbreaks.”