US regulators approved the first drug to treat Ebola on Wednesday.
Regeneron Pharmaceuticals’ drug has been approved by the Food and Drug Administration (FDA) to treat both children and adults ill with the Zaire strain of the Ebola virus, the deadliest of the six known types . The disease generally kills between 60% and 90% of patients.
The drug was one of four tested during an outbreak in the Congo that claimed nearly 2,300 lives before being controlled in June. The survival rate was significantly higher in participants who were given Regeneron’s Inmazeb drug or a second experimental drug.
The study was concluded early last year so that all patients could have access to these drugs.
The Regeneron treatment is a combination of three antibodies that work by killing the virus, and is given only once through an IV.
“When you have three drugs that are linked (to the virus), there is a low probability that the virus can evade all of them,” said Leah Lipsich, who heads Regeneron’s global infectious disease program.
Lipsich said that should prevent the virus from becoming resistant to the drug.
Seeking US approval first is a common strategy for drug companies developing treatments for diseases found primarily in the tropics and developing countries. The FDA move will make it easier for Regeneron to get the go-ahead or allow emergency use during outbreaks in African countries, where the approval process is not straightforward, Lipsich said.
The Congo study involved 681 patients, who were given one of four treatments. After four weeks, about a third of the participants who received the Regeneron drug died. The results were similar for a second drug. In contrast, nearly half of the participants in the groups that received two other treatments, ZMapp or remdesivir, died.
Gilead Science’s remdesivir is currently used as a treatment for coronavirus.
Ebola is highly contagious and is spread mainly through contact with the bodily fluids of infected people. Symptoms include fever, muscle pain, vomiting, liver and kidney damage, and sometimes internal and external bleeding.
The FDA approved the first Ebola vaccine last December.
The US government, which helped fund the development of the approved drug, will purchase thousands of doses over the next six years to supply the Strategic National Reserve. Ebola cases are rare in the United States, but are occasionally diagnosed in travelers returning from areas affected by an outbreak.
Linda A. Johnson is on Twitter as: https://twitter.com/LindaJ_onPharma