CENTOCOR ORTHO BIOTECH INC — Simponi FDA Review (NDA/BLA 125289, 2026)
CENTOCOR ORTHO BIOTECH INC · 2026 · FDA Review (Drugs@FDA)
Report summary
Simponi (golimumab) is FDA-approved for various inflammatory conditions, including a recent supplemental approval for pediatric ulcerative colitis (UC). Efficacy in pediatric UC was demonstrated in Study UCO3003, showing clinical remission at Week 6 and maintained long-term. The safety profile in pediatric patients is consistent with adults, with no new signals, though pyrexia and headache were noted. Key safety concerns across all indications include serious infections, malignancies (lymphoma, hepatosplenic T-cell lymphoma), worsening congestive heart failure, and demyelinating disorders. Common adverse reactions include upper respiratory tract infections and injection site reactions. Weight-tiered dosing for pediatric UC ensures similar exposures to adults. The report also details efficacy in adult rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and provides instructions for the SmartJect Autoinjector.
Key findings — cited to the page
| Draft IFU received by DMPP and OPDP date | August 4, 2025 | SIMPONI (golimumab) · United States · p.249 |
| Postmarketing commitment number | 5 | United States · p.253 |
| Received Date | 12/12/2024 | Global · p.69 |
| Draft MG received by DMPP and OPDP date | August 4, 2025 | SIMPONI (golimumab) · United States · p.249 |
| Draft PI received by DMPP and OPDP date | August 4, 2025 | SIMPONI (golimumab) · United States · p.249 |
| Amendment to Prior Approval Supplement date | May 1, 2025 | SIMPONI (golimumab) · United States · p.253 |
| Proposed indication | treatment of pediatric patients with ulcerative colitis (UC) | SIMPONI (golimumab) · United States · p.246 |
| Consult request date | December 13, 2024 | United States · p.246 |
| Draft labeling emailed to OPDP date | August 4, 2025 | United States · p.246 |
| Efficacy Supplement submission date | December 12, 2024 | SIMPONI (golimumab) · United States · p.249 |
| DMPP and OPDP review request date | April 16, 2025 | United States · p.249 |
| Pediatric age range for UC study | 2 through <18 years | United States · p.253 |
Source: CENTOCOR ORTHO BIOTECH INC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →