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FDA Approves Actemra to Treat Rare Form of Juvenile Arthritis
Date:4/15/2011

acebo. Response was defined as at least 30 percent improvement in the American College of Rheumatology's JIA efficacy variables, along with absence of fever in the preceding seven days. In the long-term follow-up period of the trial there were three cases of macrophage activation syndrome (MAS) among SJIA patients receiving Actemra. MAS is a potentially fatal complication of childhood systemic inflammatory disorders, thought to be caused by excessive activation and proliferation of certain immune cells.

Actemra carries a Boxed Warning for serious infections. Patients treated with Actemra who develop a serious infection should stop Actemra treatment until the infection is controlled. A Boxed Warning is a brief, concise summary of the information that is critical for a prescriber to be aware of, including any restriction on distribution or use, which is included in a black box at the beginning of the drug label.

Changes in certain laboratory test results such as liver tests, blood counts, and cholesterol are not uncommon with Actemra and should be monitored with regular blood tests. The most common side effects in trial participants with SJIA included upper respiratory tract infection, headache, sore throat, and diarrhea.

Actemra is marketed by San Francisco-based Genentech Inc., a subsidiary of the Roche Group.

For more information:

Press Release: FDA Approves New Drug for Rheumatoid Arthritis

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197108.htm

Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

National Institute of Arthritis and Musculoskeletal and Skin Diseases – Juvenile Arthritis

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SOURCE U.S. Food and Drug Administration
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