ChemoCentryx Soars On Phase III Avacopan Data In ANCA Vasculitis
The company and partner Vifor said the selective complement 5a receptor inhibitor met both primary and multiple secondary endpoints; US and EU filings are planned for 2020.
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Failure to Heed FDA Warnings of Poor Trial Design Likely To Haunt ChemoCentryx At Advisory Cmte.
Phase III trial was statistically significant, but US FDA argues complex study design makes it unclear that ChemoCentryx’s avacopan offers a clinically meaningful benefit, including a safety advantage, for ANCA vasculitis. Agency had tried to direct company to better designed trials earlier in development program.