The U.S. Food and Drug Administration released a briefing document on May 4 citing concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. ChemoCentryx is seeking approval from the FDA for the drug as a therapeutic agent for anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (AAV).
ChemoCentryx and VFMCRP announced that the companies’ pivotal Phase III ADVOCATE clinical trial of avacopan for ANCA-associated vasculitis hit the study’s primary endpoints.
The U.S. Food and Drug Administration approved Roche/Genentech’s Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in pediatric patients 2 years of age and older.
The U.S. Food and Drug Administration approved Pfizer Inc.’s Ruxience (rituximab-pvvr) – a biosimilar to Rituxan (rituximab) – for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.
AbbVie’s biologic therapy Humira for autoimmune disorders continues to dominate the sales landscape; Gilead’s once-daily hepatitis C treatment Harvoni in 2016 repeated its performance as the world’s second-best-selling prescription medicine.