JANSSEN BIOTECH — Simponi Aria FDA Review (NDA/BLA 125433, 2018)
Johnson & Johnson · 2018 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Simponi Aria (golimumab) injection on August 5, 2015, for adults with moderately to severely active Rheumatoid Arthritis, in combination with methotrexate. The approval package details dosage, administration, and warnings regarding serious infections and malignancies. Subsequent reviews focused on incorporating SF-36 health survey data into the product labeling, demonstrating significant improvements in physical and mental health components for patients. Clinical trials (Study 3001 and Study 12) confirmed golimumab's efficacy, showing superior ACR20 response rates and statistically significant improvements in SF-36 scores compared to placebo. The FDA confirmed a favorable risk-benefit profile with no new safety concerns, reiterating existing boxed warnings for TNF blockers. Regulatory communications involved requests for additional information and labeling edits to support the inclusion of SF-36 results.
Key findings — cited to the page
| ACR 50 response | 35 % | Trial 1 · p.26 |
| ACR 50 response | 30 % | Trial 1 · p.26 |
| Warnings and Precautions (5.1, 5.2, 5.9) revision date | 12/2014 | · p.9 |
| Dosage regimen | 2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks | Simponi Aria · p.9 |
| Dosage form and strength | 50 mg/4 mL (12.5 mg/mL) in a single use vial | Simponi Aria · p.9 |
| Most common adverse reactions incidence | >3% % | · p.9 |
| Dosage regimen | 2 mg per kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter | Simponi Aria · p.11 |
| Vial strength | 50 mg mg | Simponi Aria · p.11 |
| Vial volume | 4 mL mL | Simponi Aria · p.11 |
| Infusion duration | 30 minutes minutes | Simponi Aria · p.12 |
| Diluted solution storage time at room temperature | 4 hours hours | · p.12 |
| Injection strength | 50 mg mg | Simponi Aria · p.12 |
Source: Johnson & Johnson ↗ · 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 →