US approves Regeneron’s antibody treatment for Ebola
Oct 15, 2020 - 11:47 AM
WASHINGTON — The United States on Wednesday approved a lab-made antibody treatment against the Ebola virus developed by the biotech firm Regeneron after it was shown to significantly reduce the mortality rate in a clinical trial.
The drug was developed using the same technology platform that the company used to produce its experimental therapy against Covid-19, which President Donald Trump received after contracting the coronavirus.
Food and Drug Administration (FDA) Commissioner Stephen Hahn said: “Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats — both domestically and abroad — on the basis of science and data.”
The drug, called Inmazeb, is administered intravenously and is a mixture or “cocktail” of three monoclonal antibodies that bind to a surface protein (called the glycoprotein) of the Zaire ebolavirus to prevent it from invading human cells.
“We are incredibly proud that the FDA has approved Inmazeb,” added George Yancopoulos, president and chief scientific officer of New York state-based Regeneron.
Inmazeb was studied in 382 adult and pediatric patients, roughly half of whom received the drug while the other half received a control drug.
Of the patients who received Inmazeb, 33.8 percent died after 28 days, compared to 51 percent of the 153 patients who received a control drug.
The study was carried out in the Democratic Republic of Congo in 2018 and reported in the New England Journal of Medicine in 2019.
The most common side effects were fever, chills, fast heart rate and fast breathing — but these are also common symptoms of Ebola virus infection.
The FDA said patients who receive Inmazeb should avoid getting a live Ebola vaccine at the same time, since the drug will weaken the vaccine’s efficacy.
Ervebo, the first vaccine for the prevention of Ebola virus disease, was approved by the FDA in December 2019.
Monoclonal antibodies are a relatively new class of drugs that are best known for treating certain types of cancer and autoimmune disease.
Human immune systems produce antibodies, which are infection-fighting protein molecules, and vaccines teach our bodies to be prepared to make the right ones for particular pathogens.
Inmazeb is based on three highly effective antibodies against the Ebola virus that were discovered by infecting mice with genetically modified human-like immune systems.
The host immune cells that produced these molecules were then cultured in a lab to produce the desired antibodies en masse.