Abbott (NYSE: ABT) has simultaneously submitted regulatory applications for its drug product HUMIRA® (adalimumab):
- a supplemental Biologics License Application (sBLA) with the USFDA seeking approval to market HUMIRA® (adalimumab) as a treatment for juvenile rheumatoid arthritis (JRA) in the U.S.
- a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for juvenile idiopathic arthritis (JIA) in the European Union (EU).
The above regulatory applications are the first pediatric indication being sought for HUMIRA®.
JRA, commonly referred to as JIA in the EU, is the most common form of arthritis in children and normally begins before the age of 16. Typical symptoms include persistent joint pain and stiffness that are usually worse in the morning or after a nap.
The pain may limit movement of the affected joint, although many children will not complain of the pain. Walking with a limp is an early sign of JRA due to an affected knee.
HUMIRA® is the only fully human monoclonal antibody approved for the treatment of the following:
- rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) (both in the U.S. and Europe)
- Crohn's disease (in the U.S.)
HUMIRA® is currently undergoing clinical trials for its potential in other autoimmune diseases.
Find more details from the full report.
There are treatments that can help, and each person responds to the disease differently. What can you expect? That depends on many factors.
How advanced your rheumatoid arthritis is at the time you are diagnosed
Your age at the time you are diagnosed
How "active" your disease is
Each person's rheumatoid arthritis is unique, and the disease affects each person differently. Over the long-term, though, there are a few common patterns. For more information you can enter this site...
Posted by: john | June 18, 2007 3:53 AM | Permalink to Comment