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

SILVER SPRING, Md., April 15, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today approved Actemra (tocilizumab), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in children ages 2 years and older.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

SJIA, or Still's disease, is a rare, potentially life-threatening disorder in children that causes severe inflammation throughout the body. SJIA is distinguished from other forms of juvenile idiopathic arthritis (JIA) by the prominence of systemic and inflammatory features, including spiking fevers; rash; swelling and inflammation of lymph nodes, liver, and spleen; and high white blood cell and platelet counts. The prevalence of JIA is an estimated 1 to 2 per 1,000 children, and SJIA affects about 10 percent of all JIA patients.

Actemra is an interleukin-6 receptor blocker approved by the FDA on Jan. 8, 2010, for treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to other approved therapies.

"This new indication of Actemra provides the first approved therapy for children with this rare disease," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

An international, multicenter controlled trial demonstrated the safety and effectiveness of Actemra, in which 112 patients received either Actemra infusions or placebo infusions every two weeks. Study participants included patients with SJIA aged 2 to 17 years old who had inadequate response to or who were unable to take nonsteroidal anti-inflammatory drugs and corticosteroids.

Eighty-five percent of those receiving Actemra responded to treatment, compared with 24 percent of patients receiving placebo. 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

http://www.niams.nih.gov/Health_Info/Juv_Arthritis/default.asp

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves New Medical Device for Form of Brain Cancer
2. FDA Approves the NovoTTF-100A System for the Treatment of Patients With Recurrent Glioblastoma Multiforme (GBM) Brain Tumors
3. FDA Approves Horizant To Treat Restless Legs Syndrome
4. FDA Approves New Treatment for Rare Form of Thyroid Cancer
5. FDA Approves Special Protocol Assessment for Phase 3 Trial of Polaris Groups Cancer Therapeutic, ADI-PEG 20, in the Treatment of Hepatocellular Carcinoma
6. FDA Approves Hyperopia Application for the MEL 80 Excimer Laser from Carl Zeiss Meditec
7. FDA Approves New Treatment for a Type of Late-Stage Skin Cancer
8. FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age
9. FDA Approves Gadavist for Central Nervous System Scans
10. U.S. FDA Approves Bayers Gadavist™ (Gadobutrol) Injection for MRI of the Central Nervous System
11. FDA Approves Device to Maintain Blood Flow During Artery Bypass Brain Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... , May 27, 2016 ... innovative biopharmaceutical company focused on late-stage drug development, ... Dexcel Pharma of pivotal batches required for ... Drug Administration (FDA). This follows Kitov,s announcement ... III trial successfully met its primary efficacy endpoint. ...
(Date:5/26/2016)... 2016 TARE (Transarterial Radio-embolization) ... Savings and Overall Decreased Use of Hospital ... international specialist healthcare company, has today announced the ... Meeting of ISPOR (International Society for Pharmacoeconomics and ... (HCC) using yttrium-90 glass microspheres is associated with ...
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 ... bedient dringenden Bedarf zur ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt ... und Entwicklungsvereinbarung mit Therawis Diagnostics GmbH zur Entwicklung ... zu sein. Ein erstes Projekt wird die Entwicklung ...
Breaking Medicine Technology:
(Date:5/28/2016)... ... 2016 , ... May 26, 2016- In search of the K. Warriors, Shaolin ... of “K Warriors” on June 4, 2016 at Ashbury Hotel and Suites 600 West ... and hosted by Shaolin Institute and sanctioned by KSF (Kungfu Sanda Federation), This is ...
(Date:5/27/2016)... ... 27, 2016 , ... Southland Log Homes , designer and manufacturer of ... kits, which can be found on its website at SouthlandLogHomes.com. , The designs of ... they highlight the craftsmanship of timber post and beam construction. The result is ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... With over ... to walk, the demand for a sustainable product to aid in the rehabilitation process ... aid in the recovery of individuals with hemiplegia due to stroke. , Ekso Bionics ...
(Date:5/27/2016)... , ... May 27, 2016 , ... Beleza Medspa ... body fat composition regulations. This is the first time that Coolsculpting is being ... at least every six months to ensure they meet the prescribed body-fat standard, measured ...
(Date:5/27/2016)... ... May 27, 2016 , ... With a team ... and food industries. Aside from its GMP accreditation, Validation Center is also a ... certified products, services and staff. , Validation Center is ISO17025 accredited and only ...
Breaking Medicine News(10 mins):