The U.S. Food and Drug Administration has given its approval to a drug to treat Ebola virus that has been created by Tarrytown-based Regeneron.
Inmazeb is a mixture of three monoclonal antibodies and was designed to treat Zaire ebolavirus. It is the first FDA-approved treatment for Ebola virus infection in adult and pediatric patients.
FDA Commissioner Stephen M. Hahn said: “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.”
Inmazeb was evaluated in 382 adult and pediatric patients with confirmed Zaire ebolavirus infection in a clinical trial and as part of an expanded access program conducted in the Democratic Republic of the Congo during an Ebola virus outbreak in 2018-19. The trial was led by the U.S. National Institutes of Health and the Congo’s Institut National de Recherche Biomédicale with contributions from several other international organizations and agencies.
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.
Regeneron’s Inmazeb targets the glycoprotein that is on the surface of Ebola virus. By blocking action of the glycoprotein the virus is kept from entering the cell. The three antibodies that make up Inmazeb can bind to this glycoprotein simultaneously and block attachment and entry of the virus.
John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said: “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.”
Inmazeb received an Orphan Drug designation for the treatment of Ebola virus infection. The Orphan Drug designation provides incentives to assist and encourage drug development for rare diseases. Additionally, the FDA granted Inmazeb a Breakthrough Therapy designation for the treatment of Zaire ebolavirus infection.
Regeneron currently is studying the application of monoclonal antibodies in the treatment and prevention of coronavirus, Covid-19. President Donald Trump received a dose of a Regeneron monoclonal antibody cocktail as part of his treatment for Covid-19.