Johnson & Johnson — Stelara FDA Review (BLA761044, ORIG 1, 2016)
Johnson & Johnson · 2016 · FDA Review (openFDA) · company profile →
Report summary
This clinical review recommends approval of ustekinumab (Stelara) for moderately to severely active Crohn's disease, based on comprehensive efficacy and safety data from pivotal Phase 3 studies (3001, 3002, 3003). The recommended regimen is a weight-tiered IV induction dose of approximately 6 mg/kg, followed by a 90mg SC every 8-week maintenance dose. The review highlights the superior efficacy of the 6mg/kg induction and q8w maintenance regimens, noting the inferiority of the q12w dosing arm. Efficacy endpoints included clinical response, remission, and improved quality of life, with some improvements in biomarkers. Safety analyses covered adverse events, infections, and malignancies, with a post-marketing observational study required to assess long-term risks.
Key findings — cited to the page
| Clinical Response at Week 6 (Induction Study 3002) | 55.5 % | Stelara (ustekinumab) Induction Study 3002 · p.114 |
| Clinical Remission at Week 44 (Maintenance Study 3003) | 35.9 % | Stelara (ustekinumab) Maintenance Study 3003 · p.116 |
| Clinical Response at Week 6 (Induction Study 3001) | 21.5 % | Stelara (ustekinumab) Induction Study 3001 · p.113 |
| Clinical Response at Week 6 (Induction Study 3002) | 51.7 % | Stelara (ustekinumab) Induction Study 3002 · p.114 |
| Clinical Response at Week 6 (Induction Study 3001) | 33.7 % | Stelara (ustekinumab) Induction Study 3001 · p.113 |
| Clinical Response at Week 6 (Induction Study 3001) | 34.3 % | Stelara (ustekinumab) Induction Study 3001 · p.113 |
| Proposed Trade Name | Stelara | Stelara (ustekinumab) · p.2 |
| Number of patients randomized to ustekinumab 90 mg SC q8w in Study 3003 | 132 patients | Study 3003 · p.88 |
| Established Name | ustekinumab | Stelara (ustekinumab) · p.2 |
| Clinical Response at Week 6 (Induction Study 3002) | 28.7 % | Stelara (ustekinumab) Induction Study 3002 · p.114 |
| Applicant | Janssen Biotech, Inc. | Stelara (ustekinumab) · p.2 |
| Clinical Remission at Week 44 (Maintenance Study 3003) | 48.8 % | Stelara (ustekinumab) Maintenance Study 3003 · p.116 |
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 →