FDA Approves Otezla®for the Treatment of Oral Ulcers in Behcet’s Disease
Celgene Corporation announced on July 19 that the U.S. Food and Drug Administration (FDA) has approved Otezla® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behcet’s disease. Otezla, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only…...
Scientists use Clues in the Human Genome to Discover new Inflammatory Syndrome
“Our team of researchers at the NIH discovered a new form of vasculitis and called it VEXAS. VEXAS is caused by genetic mutations in a portion of a patient’s blood cells. Before we knew about VEXAS, these patients were diagnosed with other forms of vasculitis, such as relapsing polychondritis, polyarteritis…...
Recruiting: A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA)
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week…...
FDA approves Nucala as the first and only biologic treatment for Hypereosinophilic Syndrome (HES)
Third US indication for Nucala demonstrates GSK’s commitment to finding new ways to help patients with eosinophil-driven diseases Issued: 25 September 2020, London UK GlaxoSmithKline plc (GSK) today announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12…...
ChemoCentryx Announces FDA Acceptance of the Avacopan New Drug Application (NDA) for the Treatment of ANCA-Associated Vasculitis
MOUNTAIN VIEW, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) — ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of ANCA-Associated Vasculitis and has set July 7, 2021 as the Prescription Drug User…...
