JnJ Simponi bags USFDA okay for pediatric ulcerative colitis
Horsham: Johnson & Johnson has announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for SIMPONI (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. This approval builds on the SIMPONI indication for adults living with moderately to severely active UC, which together represents more than one million Americans living with this condition.
“Ulcerative colitis is a complex, lifelong condition that is often challenging to manage effectively, particularly for pediatric patients, where relatively few approved options are available,” said Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “The approval of SIMPONI represents a meaningful milestone, offering a therapy with well-established efficacy and safety along with subcutaneous dosing, for younger patients where treatment options have historically been limited.”
The approval is supported by data from the PURSUIT program, which included two multi-center, open-label studies to evaluate the efficacy, safety, and pharmacokinetics of subcutaneously administered SIMPONI for the treatment of pediatric UC. In the Phase 3 PURSUIT 2 study, the primary endpoint of clinical remission at Week 6 was achieved by 32% of patients. The secondary endpoints of clinical response at Week 6 was achieved by 58% and endoscopic improvement at Week 6 was achieved by 40% of patients receiving SIMPONI. Among patients treated with SIMPONI who were in clinical remission at Week 6, 57% maintained clinical remission of symptoms at Week 54. Safety results for this population are consistent with clinical trials of SIMPONI in adults with UC.
SIMPONI is administered as a pre-filled syringe and can be self-administered for patients aged 12 years and older after proper training by a healthcare provider. The recommended dosage for pediatric patients weighing at least 40 kg is 200 mg at Week 0, followed by 100 mg at Weeks 2, 6, and every 4 weeks thereafter; for pediatric patients weighing at least 15 kg to less than 40 kg, SIMPONI is administered at 100 mg at Week 0, followed by 50 mg at Weeks 2, 6, and every 4 weeks thereafter.
This is the first pediatric approval for SIMPONI, which is already approved for four indications, including adults living with moderate to severe rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS) and moderately to severely active UC.
