Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.
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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.
The global COVID-19 pandemic is prompting an unprecedented effort to develop a vaccine in record-breaking time. But there may be pitfalls in letting optimism run too far ahead of the realities of vaccine development.
Epidemiology complicates field efficacy trials, but US FDA advisory committee members regretfully agree that data from non-human primate passive transfer studies is compelling but potentially insufficient for chikungunya vaccines.