US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics
FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.
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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.
Gilead and Roche ended the year involved in three novel agents apiece, thanks to a combination of internal research and external licensing.
Dermatology, chronic kidney disease and liver disease therapies stand out in a crowd of user fee goals that is actually bigger than at the same point in 2020.