The U.S. Food and Drug Administration (FDA) on Wednesday approved the world’s first successful treatment for the Ebola virus, a major ste...
The U.S. Food and Drug Administration (FDA) on Wednesday approved the world’s first successful treatment for the Ebola virus, a major step against one of the world’s deadliest pathogen.
The FDA gave its formal blessing to Inmazeb, a mixture of three monoclonal antibodies produced by the American pharmaceutical company Regeneron, after a trial among 382 adult and pediatric patients in the Democratic Republic of the Congo.
The new treatment is a breakthrough, but not one that completely eliminates the threat of a virus that can kill as many as nine in ten of those who contract it if they are not treated.
The mortality rates among patients who received the drug was substantially lower than those who were treated for the virus without the drug. About a third of those receiving the drug died, compared to just over half of those who did not.
The drug’s development was funded by a public-private partnership between Regeneron and the Biomedical Advanced Research and Development Authority. The National Institutes of Health and Congo’s Health Ministry helped administer the study.
“The approval of the first-ever therapeutic for Ebola is a momentous global health achievement that would have never occurred without American leadership,” Health and Human Services Secretary Alex Azar said in a statement Wednesday.
The Ebola virus has infected humans almost a dozen times in Congo in modern history. An outbreak in Equateur Province, along the Congo River, had infected more than 100 people by mid-September, according to the World Health Organization. That conflagration erupted just as Congo’s worst-ever epidemic, in two eastern provinces along the borders with Uganda and Rwanda, came under control.
Global health officials got that outbreak under control in part with the help of an American-developed vaccine, also the first of its kind.
Both the treatment and the vaccine were developed in the wake of the world’s worst-known Ebola outbreak, which struck three West African countries in 2014 and 2015. More than 11,300 people died in that epidemic.
The new drug is meant to treat the most common form of the Ebola virus, the Zaire strain that was first identified in 1976, before the DRC changed its name. Zaire ebolavirus has infected far more people than the other four known strains of Ebola, and it kills a substantially higher percentage of its victims.