Regeneron's Inmazeb Overcame FDA Combo Product Requirements With Nonclinical Evidence

Regeneron Pharmaceuticals, Inc. relied on nonclinical data to satisfy US Food and Drug Administration requirements for fixed-combination drug product efficacy because it could not clinically test the individual contribution of each monoclonal antibody in Inmazeb, its “cocktail” treatment for Ebola virus infection.

For Inmazeb, a factorial clinical study design “was not used and may not be appropriate because of the highly lethal nature of EBOV infection and components of the combination administered individually could lead to rapid development of resistance,” the FDA’s multidisciplinary