The U.S. Food and Drug Administration (FDA) announced the first approval of a therapeutic specifically to treat Ebola, which is currently spreading in the Democratic Republic of the Congo (DRC). Here’s why this is an amazing feat—and what it means for COVID-19 treatments.
BIO member Regeneron’s Inmazeb is an antibody cocktail. The drug was shown to significantly reduce mortality in a 2018-2019 trial during an Ebola outbreak in the DRC, reports STAT News.
How it works: “The treatment consists of three monoclonal antibodies of similar structure, atoltivimab, maftivimab, and odesivimab, that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein. The three antibodies help neutralize the Ebola virus by blocking its ability to invade patients’ and/or enlisting other immune cells to target infected cells and remove them from the body,” according to Regeneron.
What’s next: In partnership with the Biomedical Advanced Research and Development Authority (BARDA), Regeneron will supply doses to the Strategic National Stockpile as well as provide the drug for free in response to outbreaks in the DRC.
What FDA’s saying: “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,” said FDA Commissioner Dr. Stephen Hahn.
What Regeneron’s saying: “Decades of investment in our VelociSuite® rapid response technologies, the dedication of world-class scientists, and the courageous contributions of healthcare providers and patients, together with remarkable cooperation between leading international health organizations and governments, have led to this important moment,” said Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron.
This is no easy feat. Developing a new drug takes a long time—sometimes 10-15 years from discovery to approval—and 9 in 10 drugs that begin clinical testing ultimately fail, making it a risky investment.
Looking ahead: Regeneron’s COVID-19 antibody cocktail—which President Trump received—has so far shown to reduce viral load and alleviate symptoms.
“As we apply the same sophisticated technologies and manufacturing capabilities against COVID-19, we hope this will be one of many demonstrations of how the power of science can be successfully deployed against dangerous infectious diseases,” said Dr. Yancopoulos.
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“They show that the researchers were following proper safety procedures.”
