Inmazeb FDA approval : Regeneron Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its antibody cocktail Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus (Ebola virus).
Formerly known as REGN-EB3, Inmazeb is now the first drug regimen to get FDA approval for Ebola treatment, covering adult and pediatric patients, which includes newborns of mothers who tested positive to the Ebola virus.
Commenting on Inmazeb FDA approval for Ebola, Stephen M. Hahn – FDA Commissioner, 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.”
Inmazeb has been designed to target the glycoprotein found on the surface of the Ebola virus. Glycoprotein attaches to the cell receptor and fuses the viral and host cell membranes to facilitate the entry of the Ebola virus into the cell.
The three antibodies present in the drug regimen can bind simultaneously to the glycoprotein, thereby blocking attachment and also the entry of the Ebola virus.
Inmazeb FDA approval was driven by the results of the PALM trial, a randomized, multicenter, controlled study that was initiated a couple of years ago in the Democratic Republic of Congo. The PALM trial, which had 681 participants, was successful in establishing the safety and efficacy of the three-drug regimen.
Leonard S. Schleifer – Co-Founder, President and CEO of Regeneron Pharmaceuticals, commenting on Inmazeb FDA approval, said: “Developed using Regeneron’s proprietary VelociSuite rapid response technologies, REGN-EB3 was shown to save lives in the PALM trial, which evaluated multiple therapies against the previous standard of care for Ebola.
“Regeneron’s thirty years of investment in our technology and people enabled the development of REGN-EB3, which reinforces the importance of having at-the-ready tools to fight emerging pathogens.
“As we push through the current COVID-19 pandemic, it’s important for governments and industry to ensure preparedness for the next global health crisis by continuing to invest in innovative science and broad manufacturing capacity.”