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US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols

 
• By Sue Sutter

Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.

Drug Review Profile: Inmazeb & Ebanga
Inmazeb and Ebanga were approved for Ebola infection based on data from a multi-arm trial. • Source: Alamy

The US National Institutes of Health-led ACTIV clinical trial program is using master protocols to quickly assess the efficacy of potential COVID-19 therapeutics. One need look no further than the Food and Drug Administration’s recent approval of two Ebola virus treatments to see the kinds of efficiencies possible with this approach, particularly in the context of quickly emerging infectious disease outbreaks.

The Ebola drugs – Regeneron Pharmaceuticals, Inc.’s Inmazeb (atoltivimab/maftivimab/odesivimab-ebgn) and Ridgeback Biotherapeutics LP’s Ebanga (ansuvimab-zykl) – were approved based on data from a single, multi-arm, adaptive trial in...

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