Failure to Heed FDA Warnings of Poor Trial Design Likely To Haunt ChemoCentryx At Advisory Cmte.

 
• By Sarah Karlin-Smith
  
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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.

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ChemoCentryx failed to listen to FDA’s criticism of their pivotal study design. • Source: Aaron Amat / Alamy Stock Photo

The US Food and Drug Administration poked numerous holes in ChemoCentryx, Inc.’s application for avacopan in anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis in briefing documents leading up to the company’s 6 May advisory panel, most of which might have been avoided if the company had listened to the agency’s advice on trial design earlier in the drug’s development.

FDA wants the Arthritis Advisory Committee to discuss not only the benefit-risk profile of avacopan but the context of use...

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