JANSSEN BIOTECH — Tremfya FDA Review (NDA/BLA 761061, 2026)
Johnson & Johnson · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
Janssen Biotech's Tremfya (guselkumab) injection received FDA approval for moderately to severely active ulcerative colitis (UC), supported by robust efficacy data from the QUASAR program (IS-1, IS-2, MS) demonstrating significant clinical remission and endoscopic improvement. The safety profile, consistent with previously approved indications (plaque psoriasis, psoriatic arthritis), showed no new signals, though postmarketing studies for pediatric patients and pregnancy are required. The approval includes new drug presentations and user-friendly devices (prefilled syringe, autoinjector), with human factors studies confirming safe use. Pharmacokinetic analyses confirmed dose proportionality and no need for adjustments based on intrinsic factors. Labeling updates, including a Medication Guide and Instructions for Use, were finalized. The benefit-risk assessment favored approval, with flexible dosing options.
Key findings — cited to the page
| IGA score of 0 or 1 with a ≥2 grade improvement (%) | 31 % | · p.28 |
| IGA score of 0 or 1 with a ≥2 grade improvement (%) | 14 % | · p.28 |
| DILI severity: Fatal (Grade 5) (liver injury cases) | 1 | · p.483 |
| New drug presentation | 200 mg/20 mL (10 mg/mL) single-dose vial | Tremfya (guselkumab) injection · p.4 |
| Pediatric study waiver | ages less than 2 years | · p.5 |
| Pediatric study deferral | ages 2 to <18 years | · p.6 |
| New drug presentation | 200 mg/2 mL single-dose prefilled syringe | Tremfya (guselkumab) injection · p.4 |
| Postmarketing study 4696-1: Study Completion | 07/2028 | Tremfya (guselkumab) in pediatric patients 2 to <18 years of age with moderately to severely active ulcerative colitis · p.6 |
| Postmarketing study 4696-1: Final Report Submission | 01/2029 | Tremfya (guselkumab) in pediatric patients 2 to <18 years of age with moderately to severely active ulcerative colitis · p.6 |
| Postmarketing study 4696-2: Final Protocol Submission | 04/2025 | Long-term extension study for Tremfya (guselkumab) in pediatric ulcerative colitis patients · p.6 |
| Postmarketing study 4696-2: Study Completion | 02/2030 | Long-term extension study for Tremfya (guselkumab) in pediatric ulcerative colitis patients · p.6 |
| Postmarketing study 4696-1: Final Protocol Submission | 04/2025 | Tremfya (guselkumab) in pediatric patients 2 to <18 years of age with moderately to severely active ulcerative colitis · p.6 |
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 →