- Most expected CCXI to have achieved regulatory approval for avacopan to treat ANCA-Associated Vasculitis on July 7, 2021.
- Regulatory review is ongoing with the PDUFA extended to Oct. 6, 2021, in response to new filing by CCXI which the FDA designated as a major amendment to the NDA.
- The good news is that CCXI has not been issued the dreaded complete response letter.
- The outcome of the PDUFA is dependent on a satisfactory rebuttal to the Adcom questions and comments.
- Read on for details on the potential regulatory review outcome.
For further details see:
ChemoCentryx And Avacopan In ANCA-Associated Vasculitis: Making Amends