JnJ seeks USFDA approval for Simponi to treat pediatric ulcerative colitis

Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. It is the result of the immune system’s overactive response. Patients can experience a range of unpredictable symptoms, which may include loose and more frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.

More than one million people in the U.S. are living with UC, making it one of the largest populations globally affected by this disease, and approximately 20 percent of those individuals are children. Ulcerative colitis can be a challenging disease to treat especially in younger populations, reinforcing the need for additional treatment options.

Developed by Johnson & Johnson, SIMPONI is an anti-TNF biologic medicine that targets and blocks a protein called TNF-alpha (tumor necrosis factor-alpha).

SIMPONI is a prescription medicine approved in the U.S. to treat:

· adults with moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate (MTX)

· adults with active psoriatic arthritis (PsA), alone or with the medicine MTX

· adults with active ankylosing spondylitis (AS)

· adults with moderately to severely active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated, or if it is necessary to continue taking steroid medicines.

SIMPONI is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults living with the above condition(s).