JnJ seeks USFDA approval for Simponi to treat pediatric ulcerative colitis
Developed by Johnson & Johnson, SIMPONI is an anti-TNF biologic medicine that targets and blocks a protein called TNF-alpha.
Horhsam: Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of SIMPONI (golimumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC).
SIMPONI is currently approved for the treatment of adults living with moderately to severely active UC.
The sBLA is supported by data from the PURSUIT program, which include multi-center, open-label studies evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered SIMPONI for the treatment of pediatric UC.
“This submission marks an important step in addressing the unique and pressing high unmet needs of children and adolescents living with ulcerative colitis, a challenging and lifelong inflammatory disease,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “At Johnson & Johnson, we are committed to designing clinical programs that prioritize underrepresented populations, including pediatric patients living with immune-mediated diseases, to ensure access to safe and effective treatment options. We look forward to working with the Agency in their review of this SIMPONI pediatric application.”
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).
