ChemoCentryx’s Avacopan May Need Another Trial After Tepid Advisory Committee Vote
Near tie goes to the US FDA? While almost every member of the Arthritis Advisory Committee agreed with agency’s assessment that ChemoCentryx’s trial of avacopan for ANCA vasculitis was poorly designed, making it hard to tease out the drug’s benefit-risk profile, about half were in favor of approval due to the potential to spare patients from the adverse effects of steroids. Others said the sponsor didn’t meet the agency’s standard for approval off just one pivotal study.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
ChemoCentryx gets US approval of Tavneos for ANCA vasculitis, which it says may gradually ramp up to a blockbuster revenue opportunity. Current steroid-heavy standard of care has many drawbacks.
User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.