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.
2017 Annual Report – Top 200 Medicines: Humira Remains Atop The Throne
Analysts, August 2017, Autoimmune Diseases, Autoimmune Disorders, Biologics, Biosimilars, Blockbusters, Blood Cancers, Breast Cancer, Cervical Cancer, Colorectal Cancer, Forecasts, Forecasts, Gastroenterology, Hepatitis C, Immunology, Inflammatory Diseases, Japan, Kidney Cancer, Mantle Cell Lymphoma (MCL), Multiple Myeloma, Ovarian Cancer, Pneumococcal Disease, Pneumonia, Relapsed Glioblastoma, Rheumatoid Arthritis, Rheumatology, Special Reports, Therapeutics, Top 200 Medicines, Tumor Necrosis Factor (TNF) Inhibitors, Ulcerative Colitis, Vaccines, VasculitisAbbVie’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.