BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

FDA Approves Genentech (RHHBY)'s Actemra to Treat Rare Form of Juvenile Arthritis


4/15/2011 4:31:09 PM

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



Read at BioSpace.com
Read at Reuters
Read at The Business Journals
Read at RTT News

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES