CHICAGO (NewsNation Now) — The U.S. Food and Drug Administration announced Wednesday it approved Inmazeb, a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Ebola virus infection in adult and pediatric patients.
“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 Stephen M. Hahn, M.D. in a statement from the administration. “This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.”
The FDA said Inmazeb can block the virus from attaching to and entering a cell by targeting the glycoprotein that is on the surface of Ebola virus. The treatment was evaluated in 382 adult and pediatric patients with confirmed infections in one clinical trial and as part of an expanded access program conducted in the Democratic Republic of the Congo during an Ebola virus outbreak in 2018-2019.
The FDA is granting approval to Regeneron Pharmaceuticals.
“Today’s approval highlights the importance of international collaboration in the fight against Ebola virus,” said John Farley, M.D., MPH, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “The urgent need for advanced therapies to combat this infectious disease is clear, and today’s action is a significant step forward in that effort.”
According to the FDA, Zaire ebolavirus, commonly known as Ebola virus, is transmitted through direct contact with blood, body fluids and tissues of infected people or wild animals, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids. Individuals who provide care for people with Ebola virus, including health care workers who do not use correct infection control precautions, are at the highest risk for infection.