JANSSEN BIOTECH — Stelara FDA Review (NDA/BLA 761044, 2021)
Johnson & Johnson · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details the multidisciplinary review of STELARA (ustekinumab) for ulcerative colitis (UC), building on its existing approvals for other inflammatory conditions. It covers the drug's clinical pharmacology, nonclinical toxicology, and extensive clinical trial results for UC, including induction and maintenance phases. Efficacy was demonstrated through significant clinical remission, response, and mucosal healing rates compared to placebo. The safety profile, consistent across indications, highlights common adverse reactions, serious infections, and malignancies. While the benefit-risk assessment for moderately to severely active UC is favorable, the report emphasizes postmarketing requirements for long-term safety, particularly regarding malignancy risk. Labeling recommendations and dosing regimens are also detailed.
Key findings — cited to the page
| Initial intravenous dosage | 520 mg | Stelara · p.80 |
| Clinical remission rate | 19.3 % | · p.82 |
| Approval status | approved | Stelara (ustekinumab) · p.80 |
| Initial intravenous dosage | 390 mg | Stelara · p.80 |
| Trial duration | 52 weeks | · p.81 |
| Number of patients enrolled | 961 patients | · p.82 |
| Approval status | approved | Stelara (ustekinumab) · p.80 |
| Approval status | approved | Stelara (ustekinumab) · p.80 |
| Approval status | approved | Stelara (ustekinumab) · p.80 |
| Initial intravenous dosage | 260 mg | Stelara · p.80 |
| Maintenance dosing | 90 mg | Stelara · p.80 |
| Clinical remission rate | 16.9 % | · p.82 |
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 →