FDA accepts avacopan NDA for ANCA-associated vasculitis
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The FDA has accepted a new drug application from ChemoCentryx Inc. for its orally administered small-molecule drug avacopan for the treatment of ANCA-associated vasculitis, according to a company press release.
The FDA has set a Prescription Drug User Fee Act goal date of July 7, 2021, to review the application for the drug, a first-in-class selective complement 5a receptor inhibitor, the release said.
In its acceptance letter, the FDA stated it may, but has not yet determined to, convene an advisory committee meeting to discuss the application, per guidelines for new molecular entities, according to the company.
The ChemoCentryx NDA included data from the ADVOCATE trial, an international phase 3 study of 331 patients with ANCA-associated vasculitis. According to the company, the trial found statistical superiority in sustaining remission at 52 weeks among patients treated with avacopan (CCX168), compared with those who received prednisone. Further, patients with ANCA-associated vasculitis who received avacopan demonstrated significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures, compared with the prednisone group.
The study also found that avacopan had favorable safety results, with fewer patients experiencing serious adverse events in the avacopan group than in the prednisone group.
Perspective
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David A. McLain, MD, FACP, FACR
In the evolution of treatment of ANCA-associated vasculitis, we have seen great strides over the past 50 years. In the early 1970s, Anthony Fauci, MD, and his colleagues at the NIH, developed a protocol that used a 3-to-6-month course of daily cyclophosphamide plus steroids, followed by long-term daily azathioprine (AZA) plus steroids in the treatment of AAV. More than 90% of individuals with this once 80% fatal disease experienced remission after they received cyclophosphamide-based therapy. However, an unmet need of this therapy were relapses with the need for retreatment.
Then in 2010, John Stone, MD, MPH, and Ulrich Specks, MD, were able to show that rituximab provided comparable benefits as standard therapy for ANCA-associated vasculitis using rituximab once a week for one month, plus steroids versus 3 to 6 months of daily cyclophosphamide therapy plus steroids, followed by daily AZA. This new approach proved its superiority in preventing relapse with rituximab vs. standard of care.
Now, in 2020, there appears another new addition to the treatment of AAV. Avacopan has been shown in the ADVOCATE trial to be statistically superior in sustaining remission at 52 weeks compared to the prednisone group. In the trial, the avacopan group also showed greater improvement in kidney function, significantly lower glucocorticoid toxicity, and greater improvement in health-related QoL measures compared to the prednisone group; there were also fewer adverse drug reactions in the avacopan group. It looks like we will have another medication option to use in AAV that appears to improve outcomes.
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