$ChemoCentryx (CCXI.US)$ ChemoCentryx (NASDAQ:CCXI) jumps 15...
$ChemoCentryx (CCXI.US)$ ChemoCentryx (NASDAQ:CCXI) jumps 15.3% premarket after filing an amendment to its New Drug Application (NDA) for avacopan for the treatment of Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis, addressing points raised during the FDA Advisory Committee meeting on May 6, 2021.The FDA has indicated that the filing constitutes a major amendment to the NDA and will result in the setting of a new PDUFA goal date of October 7, 2021 from previous date of July 7, 2021.The NDA is primarily based on data from the Phase III ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis.On May 6, the FDA Committee voted 9-9 on whether the efficacy data support approval of avacopan, 10-8 that the safety profile of avacopan is adequate to support approval, and 10-8 that the benefit-risk profile is adequate to support approval of avacopan at the proposed dose of 30 mg twice daily.ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels, resulting in organ damage and failure, with the kidney as the major target.
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