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Cimzia News

UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis

Posted 11 Jun 2018 by Drugs.com

Brussels, Belgium – 28th May, 07:00 CEST – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for Cimzia (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque psoriasis. Cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or pho ...

New Meds Make Inroads Against Crohn's Disease

Posted 13 Apr 2017 by Drugs.com

THURSDAY, April 13, 2017 – Fewer Americans with Crohn's disease are ending up in the hospital than in the past, according to a new federal study. Crohn's is a chronic inflammatory bowel disorder that often leads to surgery for most with the disease. Hospitalization rates for Crohn's disease remained stable in the United States between 2003 and 2013. That's a change from a study done from 1998 to ...

Drug Stelara May Ease Crohn's Disease

Posted 18 Nov 2016 by Drugs.com

THURSDAY, Nov. 17, 2016 – People with moderate to severe Crohn's disease who haven't responded to other treatments may benefit from the drug ustekinumab (Stelara), a new study suggests. Stelara is a monoclonal antibody that blocks the action of the inflammatory agents interleukin-12 and interleukin-23. The drug had been approved for the treatment of psoriasis and is now approved for treating ...

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, ...

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 ...

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

Posted 23 Oct 2013 by Drugs.com

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 wit ...

FDA Approves Cimzia for Treatment of Adult Patients with Active Psoriatic Arthritis

Posted 30 Sep 2013 by Drugs.com

BRUSSELS, Sept. 30, 2013 /PRNewswire/ - UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA). "The FDA's approval of Cimzia for the treatment of active PsA provides an additional, effective treatment option for those living with the condition.  Psoriatic arthritis ...

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 ...

FDA Medwatch Alert: Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)

Posted 4 Sep 2008 by Drugs.com

[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers ...

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)

Posted 4 Jun 2008 by Drugs.com

[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. ...

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Related Condition Support Groups

Rheumatoid Arthritis, Ankylosing Spondylitis, Crohn's Disease, Psoriatic Arthritis, Crohn's Disease - Maintenance, Crohn's Disease - Acute

Cimzia Patient Information at Drugs.com