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

 
• By Sue Sutter

The individual contribution of the three mABs in Regeneron’s Ebola treatment could not be clinically tested due to the highly lethal nature of the disease and the potential for development of resistance; instead, the FDA accepted nonclinical data demonstrating the mechanism of action for each component.

Three gears
Using a combination of three mABs is likely to reduce the chance that Inmazeb's efficacy will be impacted by resistance. • Source: Shutterstock

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...

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