The new PDUFA date for avacopan has been pushed back to October 7.
ChemoCentryx Inc. announced today that it filed to amend its New Drug Application (NDA) for avacopan, a C5a receptor inhibitor that treats anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
As a result of the amendment, filed after consultation with the US Food and Drug Administration (FDA), the Prescription Drug User Fee Act (PDUFA) goal date is now slated for October 7th — pushed back from the original date of July 7th.
The company noted that these major changes were carried out in response to the May 6 FDA Arthritis Advisory Committee meeting, in which the committee voted 9-9 on whether the efficacy data support avacopan’s approval, 10-8 on whether the safety profile supports approval, and 10-8 on whether the benefit-risk profile supports approval at the application’s proposed dose of 30 mg twice daily.
“We appreciate the opportunity to put additional data and information before the Agency, information which we believe addresses many of the issues raised at the Advisory Committee meeting,” said Thomas J. Schall, PhD, President and CEO of ChemoCentryx in a statement. “We look forward to continuing discussions with the Agency.”
Data in the NDA primarily represents findings from the Phase III ADVOCATE trial, a global, randomized, double-blind, active-controlled, double-dummy study that assessed 331 patients with ANCA-associated vasculitis across 20 countries.
Patients with the systemic disease generally experience inflammation and destruction of small blood vessels. As a result, fatal organ damage and failure, primarily of the kidney, may occur.
Current treatment options include courses of non-specific immuno-suppressants (i.e. cyclophosphamide or rituximab) add to daily administration of glucocorticoids (i.e. steroids). However, prolonged exposure to such medications may pose significant clinical risk, including death from infection.