According to a phase II clinical trial, the drug rilonacept, which inhibits the protein interleukin-1 (IL-1), substantially reduces acute gout flares that occur at the start of uric acid-reducing therapy and is noted to be generally well tolerated with no serious infections or serious adverse events occurring in relation to the treatment. The findings of the first placebo controlled study, in which IL-1 targeted therapy to prevent gout flares has been evaluated, are published in Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR). Gout, a form of inflammatory arthritis caused by the crystallization of urates in soft tissues, often affects the feet and is extremely painful causing swelling. According to a recent study in Arthritis & Rheumatism, doctor-diagnosed gout has increased in the past twenty years and currently affects 8.
Regeneron Announces FDA Acceptance Of ARCALYST reg; rilonacept Supplemental Biologics License Application For Review
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental Biologics License Application (sBLA) for ARCALYST Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy. Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of July 30, 2012. "Based on the positive data from our Phase 3 efficacy studies and the more than 1300 patients in our safety study, we believe that ARCALYST has the potential to become an important new therapy for patients with gout who are initiating uric acid-lowering therapies, " stated George D Yancopoulos, M.D., Ph.
Results from a new pharmacokinetic (PK) study presented at the annual meeting of the American College of Rheumatology (ACR) provide new evidence-based guidance for healthcare providers on using colchicine for gout flare prophylaxis in the presence of renal impairment. The findings demonstrate that colchicine can be administered safely in patients with moderate or severe renal impairment for the prevention of gout flares with appropriate dosing adjustments. In patients with mild renal impairment or end-stage renal disease (ESRD) dosing adjustments are not necessary. The study "Colchicine Dosing Guidance for Gout Patients with Varying Degrees of Renal Impairment Based on Pharmacokinetic Data, " is part of URL Pharma's ongoing clinical research program for colchicine. Colcrys ® (colchicine, USP), the only single-ingredient colchicine product approved by the U.
X-ray images known as CT scans can help confirm gout in patients who are suspected of having the painful condition but receive negative results from traditional tests, a Mayo Clinic study has found. The type of CT scan analyzed, dual-energy computed tomography, is also valuable for diagnosing people who cannot be tested with the typical method of drawing fluid from joints, researchers found. The study is being presented at the American College of Rheumatology annual scientific meeting in Chicago. Gout - the buildup of uric acid crystals in and around joints, causing inflammation and painful, potentially disabling flare-ups - has historically been portrayed as a disease of the wealthy, but it afflicts people from all walks of life. Men are likelier to develop gout, but women's risk rises after menopause, when their uric acid levels approach those of men.
Experts from NYU Langone Medical Center will present new research findings and clinical insight into the treatment of rheumatic and bone diseases in a variety of presentations at the American College of Rheumatology (ACR) 2011 Annual Scientific Meeting in Chicago, November 5-9, 2011. Press Conferences Osteoarthritis and Bone - Unintended Consequences: Increased Prescription of Narcotic Analgesics for OA in the Elderly is Associated with Increased Falls and Fractures in the Post-Vioxx Era Lydia Rolita, MD and Bruce N. Cronstein, MD Monday, November 7 at 8:30AM Following the removal of Vioxx from the market there was a marked increase in the prescription of narcotic analgesics. Subsequently, the number of falls and fractures among the elderly population with osteoarthritis also went up - which was attributed to patients prescribed narcotic analgesics.