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Ankylosing Spondylitis News

Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis

Posted 23 Oct 2013 by

ATLANTA, Oct. 18, 2013 /PRNewswire/ – regulated information – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis (AS). The FDA also issued a Complete Response Letter relating to the supplemental Biologics License Application (sBLA) of Cimzia® for the treatment of adults with active axial spondyloarthritis (axSpA). UCB is working with the FDA to determine a path forward to bring Cimzia® to US patients living with active axSpA. With these four indications, UCB confirms expected global peak sales for Cimzia of at least €1.5 billion during the second half of the decade. The approval of Cimzia for adults with active AS was based on a Phase 3, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Cimzia in patien ... Read more

Related support groups: Ankylosing Spondylitis, Cimzia, Certolizumab

Salty Diet Might Help Trigger MS, Rheumatoid Arthritis

Posted 6 Mar 2013 by

WEDNESDAY, March 6 – Eating lots of foods loaded with salt may do more than raise your blood pressure: Researchers report that it could also contribute to the development of autoimmune diseases, where the body's immune system mistakenly mounts an attack upon some part of the body. Three new studies suggest salt may be a prime suspect in a wide range of autoimmune diseases, including multiple sclerosis (MS), psoriasis, rheumatoid arthritis and ankylosing spondylitis (arthritis of the spine). A significant increase in the incidence of autoimmune diseases, especially multiple sclerosis and type 1 diabetes, suggests that environmental factors, and not genetics, may explain the trend, the researchers noted. "The diet does affect the autoimmune system in ways that have not been previously recognized," said senior study author Dr. David Hafler, a professor of neurology and immunobiology at ... Read more

Related support groups: Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Ankylosing Spondylitis, Rheumatoid Lung

Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications

Posted 31 Jul 2012 by

DEERFIELD, Ill., July 26, 2012 /PRNewswire/ – Horizon Pharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Rayos (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). The FDA approval was supported by data bridging the pharmacokinetics of Rayos to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with Rayos experienced a statistically significant improvement in ACR20 response criteria compared to placebo. The CAPRA-1 trial supported the overall safety of Rayos. "We are extremely pleased the ... Read more

Related support groups: Rheumatoid Arthritis, Prednisone, Asthma, Psoriatic Arthritis, Ankylosing Spondylitis, Polymyalgia Rheumatica, COPD

FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers

Posted 3 May 2010 by

WILMINGTON, Del., April 30 /PRNewswire-FirstCall/ – AstraZeneca and Pozen Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.(1) Vimovo, co-developed by Pozen Inc. and AstraZeneca, is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking Vimovo experienced significantly ... Read more

Related support groups: Rheumatoid Arthritis, Osteoarthritis, Naproxen, Ankylosing Spondylitis, Esomeprazole, NSAID-Induced Ulcer Prophylaxis

Simponi Approved for Immune-Related Arthritis

Posted 24 Apr 2009 by

FRIDAY, April 24 – Simponi (golimumab) has been approved by the U.S. Food and Drug Administration to treat three forms of arthritis that occur when the body's immune system attacks the joints. The injected drug, administered once a month, was sanctioned to treat moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis, the agency said in a news release. It's among a class of drugs that target tumor necrosis factor-alpha (TNF-α). When overproduced, this protein can cause inflammation and damage to bones, cartilage, and tissue. As with similar medicines, Simponi's label will include a so-called "black-box" warning that users face an increased risk of tuberculosis and invasive fungal infections, the FDA said. Common side effects of the drug include upper respiratory tract infection, sore throat, and nasal congestion. Simponi is marketed by ... Read more

Related support groups: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

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