Author Archives: Joana Carvalho

FDA to Consider Avacopan as Potential Oral Treatment of AAV

The U.S. Food and Drug Administration (FDA) has accepted for review ChemoCentryx‘s application requesting the approval of avacopan to treat ANCA-associated vasculitis (AAV), the company announced in a press release. The agency expects to announce its decision regarding approval on or before July 7, 2021.

ChemoCentryx Asks FDA to Approval Oral Avacopan to Treat AAV

ChemoCentryx is asking the U.S. Food and Drug Administration (FDA) to approve avacopan, a potential oral treatment for people with ANCA-associated vasculitis (AAV). The request, in the form of a new drug application (NDA), is based on data from the ADVOCATE Phase 3 trial (NCT02994927) in adult patients.