Regeneron Pharmaceuticals’ antibody cocktail Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) has been approved by the US Food and Drug Administration (FDA) for the treatment of Zaire ebolavirus (Ebola virus).
Inmazeb, which was previously called REGN-EB3, is now the first treatment to have been approved by the FDA for Ebola.
The antibody cocktail has been indicated for the treatment of adult and paediatric patients, including newborns of mothers who have contracted the viral infection.
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.
“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.”
According to the FDA, Inmazeb works by targeting the glycoprotein present on the surface of Ebola virus. Glycoprotein binds to the cell receptor and fuses the viral and host cell membranes to enable the entry of the virus into the cell, said the regulator.
The three antibodies that constitute Inmazeb can simultaneously attach to the glycoprotein and prevent attachment and entry of the virus.
The FDA approval for Inmazeb was based on the findings of the PALM trial, which was a randomised, multicentre, controlled study launched in 2018 in the Democratic Republic of Congo. The trial, which established the safety and efficacy of the antibody cocktail, featured a total of 681 participants.
Regeneron Pharmaceuticals president and chief scientific officer George Yancopoulos said: “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 organisations and governments, have led to this important moment.
“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.”
in July 2020, Regeneron Pharmaceuticals signed a deal worth around $345m with the US government for supplying a predetermined number of Inmazeb treatment doses. The supply will be to the Biomedical Advanced Research and Development Authority (BARDA) over the course of six years up to 2026.