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Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra for use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis

Posted 22 Oct 2013 by Drugs.com

Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra® for use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis     This is the sixth FDA approval for Actemra in four years, following previous approvals for the treatment of adults with moderately to severely active rheumatoid arthritis and children two years of age and older with active polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.     Actemra is now approved as a subcutaneous formulation to treat adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief.     Actemra is the first and only humanized interleukin-6 receptor-antagonist monoclonal antibody approved by the FDA for both subcutaneous a ... Read more

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FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis

Posted 30 Apr 2013 by Drugs.com

BASEL, April 30, 2013 – Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two years of age and older with active disease. Actemra can be given alone or in combination with methotrexate (MTX) in people with PJIA. PJIA is a form of juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis, a chronic disease of childhood.1 JIA affects approximately 100 in every 100,000 children2 of which PJIA accounts for around 30 percent.3 PJIA is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.3 “Polyarticular juvenile idiopathic arthritis is a rare debilitating condition in children that w ... Read more

Related support groups: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Arthritis, Actemra, Juvenile Idiopathic Arthritis, Tocilizumab, Juvenile Chronic Polyarthritis

Drugs Hold Promise for Severe Juvenile Arthritis Patients

Posted 19 Dec 2012 by Drugs.com

WEDNESDAY, Dec. 19 – Children who suffer from a rare and painful form of arthritis that's accompanied by fever and rashes may soon have more treatment options. Two studies published in the Dec. 20 issue of the New England Journal of Medicine suggest that two drugs – canakinumab and tocilizumab – reduce symptoms, including severe joint pain experienced by children with systemic juvenile idiopathic arthritis (JIA). "Systemic juvenile idiopathic arthritis is a form of severe arthritis which until a few years ago was treated mainly with corticosteroids which have known side effects, especially growth impairment," said Dr. Nicolino Ruperto, a pediatric rheumatologist at G. Gaslini Children's Hospital in Genoa and co-author of the studies. The research looked at the safety and effectiveness of the interleukin-1 inhibitor canakinumab and the interleukin-6 inhibitor tocilizumab. The disease ... Read more

Related support groups: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Actemra, Juvenile Idiopathic Arthritis, Tocilizumab, Canakinumab, Ilaris

Newer Rheumatoid Arthritis Drugs Don't Raise Cancer Risk: Study

Posted 6 Sep 2012 by Drugs.com

THURSDAY, Sept. 6 – A new review finds that rheumatoid arthritis medications known as biologics don't raise the risk of cancer, contrary to what some previous research has suggested. Rheumatoid arthritis affects an estimated 1 percent of the general population, with women three times more likely to have it. Different from age-related osteoarthritis, rheumatoid arthritis is debilitating autoimmune disorder that causes inflammation of the lining of the joints. Biologics work by targeting specific parts of the immune system involved in the inflammation process. Previous studies have raised questions about whether the drugs might boost the risk of cancer. The new study appears in the Sept. 5 issue of the Journal of the American Medical Association. The researchers, led by a researcher at the University of Texas M.D. Anderson Cancer Center, looked at 63 randomized controlled trials of the ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Enbrel, Remicade, Rituxan, Orencia, Cimzia, Simponi, Rituximab, Actemra, Infliximab, Etanercept, Kineret, Tocilizumab, Adalimumab, Golimumab, Abatacept, Anakinra, Certolizumab

FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)

Posted 18 Apr 2011 by Drugs.com

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr 15, 2011 - Genentech, a member of the Roche Group today announced that the U.S. Food and Drug Administration (FDA) approved Actemra (tocilizumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older. Actemra can be given alone or in combination with methotrexate in patients with SJIA. Actemra is the first medicine approved by the FDA for the treatment of SJIA, a rare and severe form of arthritis affecting children. SJIA has the worst long-term prognosis of all types of childhood arthritis.1 "Today's FDA approval marks an important advance in the treatment of SJIA, a debilitating condition affecting children," said Hal Barron, M.D., chief medical officer and head Global Product Development. "As the first and only approved treatment for SJIA, Actemra offers a new option for this ... Read more

Related support groups: Actemra, Juvenile Idiopathic Arthritis, Tocilizumab

FDA Grants Supplemental Approval for Actemra (tocilizumab)

Posted 8 Jan 2011 by Drugs.com

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jan 5, 2011 - Genentech, Inc., a member of the Roche Group, today announced that the United States (U.S.) Food and Drug Administration (FDA) has extended the Actemra (tocilizumab, RoActemra in the European Union) label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate (MTX). The supplemental approval comes one year after initial U.S. approval and supports the efficacy of Actemra in treating RA. RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications. Joint damage often begins early in the disease and can ... Read more

Related support groups: Rheumatoid Arthritis, Actemra, Tocilizumab

Rheumatoid Arthritis Drug Carries Risk Of Potentially Fatal Allergic Reaction

Posted 20 Sep 2010 by Drugs.com

From Canadian Press DataFile (September 17, 2010)   TORONTO – The maker of a drug used to treat rheumatoid arthritis is updating safety information after an elderly patient taking the medication died from a severe allergic reaction. Hoffmann-La Roche Ltd., in consultation with Health Canada, said allergic reactions can occur from Actemra (tocilizumab) and patients should be closely monitored while taking the drug. Actemra is administered intravenously to treat adults with moderate to severe rheumatoid arthritis. No Canadian cases of anaphylactic reaction have been reported. The company said in an advisory Friday that the patient who died had a long history of rheumatoid arthritis and had also been taking other rheumatoid arthritis medications before and after starting treatment with Actemra. The patient was also on blood pressure medications. The company said this is the first ... Read more

Related support groups: Actemra, Tocilizumab

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Rheumatoid Arthritis, Juvenile Idiopathic Arthritis

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