COVID-Infected Trials: Issues Arise In US FDA Reviews, But Nothing Decisive – Yet
Complications in analysis due to the impact of COVID on trial conduct are a common factor in two recent negative advisory committee reviews, but it is safe to say that both applications were rejected primarily for other reasons. When will COVID issues be decisive for FDA?
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Advisory committee unanimously votes against bardoxolone for Alport syndrome, unconvinced drug slows progression of chronic kidney disease and concerned about safety signals suggesting it could make the disease worse. However, panel offers Reata suggestions for a better-designed trial.
The latest news about applications under FDA review, from the Pink Sheet’s US FDA Performance Tracker
Patient representative was lone ‘yes’ vote, and even she acknowledged using a broad interpretation of ‘substantial evidence.’ The only route forward for Levo may be a new trial, though expanded access could be an option in the near term.