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Simponi News

FDA Approves Simponi Aria (golimumab) for the Treatment of Adults With Active Psoriatic Arthritis or Active Ankylosing Spondylitis

Posted 26 Oct 2017 by Drugs.com

Horsham, Pa., October 20, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Today’s approvals follow the ...

Gene Discoveries Could Help Rheumatoid Arthritis Treatment

Posted 28 Apr 2015 by Drugs.com

TUESDAY, April 28, 2015 – Genetic variations may hold clues to rheumatoid arthritis – suggesting not only who will develop the painful condition, but also predicting its severity and even who might die from it, a new study says. "Genetic factors predisposing to disease, to disease severity, and response to treatment will allow tailoring treatment to individual patients' needs," said lead ...

Smokers May Get Less Benefit From Drugs for Arthritic Back Pain

Posted 10 Feb 2015 by Drugs.com

TUESDAY, Feb. 10, 2015 – Smoking may hamper the effects of certain drugs used to treat inflammatory arthritis in the lower back, a new study from Switzerland says. Researchers from University Hospital Zurich looked at how 700 people with this type of arthritis responded to treatment with a class of drugs called tumor necrosis factor (TNF) inhibitors. About two-thirds of the patients were ...

Certain Autoimmune Drugs in Pregnancy May Up Newborn Infection Risk: Study

Posted 3 Oct 2014 by Drugs.com

FRIDAY, Oct. 3, 2014 – When given to pregnant women, a common treatment for ulcerative colitis may inadvertently lower their baby's ability to fight off infections at birth, new French research suggests. The treatment, called anti-TNF therapy, is an injected, artificial antibody. This type of medication is widely seen as a safe and effective way to tackle a wide range of autoimmune disorders, ...

Many Rheumatoid Arthritis Patients May Skip Meds: Study

Posted 3 Sep 2014 by Drugs.com

WEDNESDAY, Sept. 3, 2014 – Many patients with severe rheumatoid arthritis don't take their expensive medications as prescribed, a new British study finds. Failure to take the drugs correctly reduces their effectiveness and may lead to a worsening of symptoms, warned researchers from the University of Manchester. Rheumatoid arthritis develops when your immune system begins to attack itself, and ...

Popular Crohn's, Colitis Drugs Not Linked to Short-Term Cancer Risk: Study

Posted 18 Jun 2014 by Drugs.com

WEDNESDAY, June 18, 2014 – A popular class of drugs used to treat inflammatory bowel disease isn't linked to an increase in the short-term risk of cancer, Danish researchers report. Researchers found that people with Crohn's disease or colitis who received the drugs – tumor necrosis factor alpha (TNF-a) antagonists – had about the same risk of cancer as other people with these inflammatory ...

Simponi Aria (golimumab) for Infusion Receives FDA Approval for Treatment of Moderately to Severely Active Rheumatoid Arthritis

Posted 19 Jul 2013 by Drugs.com

First Anti-TNF Infusion Therapy Approved in More Than a Decade for Patients Living with Moderately to Severely Active Rheumatoid Arthritis HORSHAM, Pa., July 18, 2013 /PRNewswire/ – Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) approval of SIMPONI® ARIA TM (golimumab) for infusion for the treatment of adults with moderately to severely ...

FDA Approves Simponi to Treat Ulcerative Colitis

Posted 15 May 2013 by Drugs.com

May 15, 2013 – The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing ...

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

Posted 6 Nov 2011 by Drugs.com

  [UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include: patient characteristics (age, gender, no patient identifiers) risk factors for malignancy exposure to other immune suppressing products or products with risk of malignancy indication for TNF blocker t ...

FDA Medwatch Alert: Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria

Posted 8 Sep 2011 by Drugs.com

including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning ...

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

Posted 16 Apr 2011 by Drugs.com

[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.  TNF blockers include Remicade (i ...

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Further Information

Related Condition Support Groups

Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Ulcerative Colitis, Spondyloarthritis

Simponi Patient Information at Drugs.com