Non-Inferiority Trials, Please, US FDA Implores Rheumatoid Arthritis Sponsors
RA drug development has been slow to revise the trial design paradigm despite agreement on the drawbacks of placebo controls and crossover elements, but FDA biostatistician Levin sees promise in non-inferiority designs.
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Although lengthy duration of placebo treatment was not flagged for concern in first-cycle review of Sanofi/Regeneron's sarilumab for rheumatoid arthritis, it drew considerable attention in the BLA's second go-around at FDA, which included an ethics consult and a center director briefing.
IL-6 inhibitor should be compared to another biologic to exclude a multi-fold increase in the risk of death, advisers say; FDA assures the panel's industry representative it is not considering an across-the-board requirement for large safety studies of rheumatoid arthritis treatments.
Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors Sought For Poziotinib, Brexafemme
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.