CENTOCOR ORTHO BIOTECH INC — Stelara FDA Review (NDA/BLA 125261, 2019)
CENTOCOR ORTHO BIOTECH INC · 2019 · FDA Review (Drugs@FDA)
Report summary
This FDA approval package for Stelara (ustekinumab) details its approval for moderate to severe plaque psoriasis, including dosage, safety information, and adverse reactions. It covers pharmacodynamics, pharmacokinetics, nonclinical toxicology, and clinical efficacy from studies 1 and 2, showing PASI 75 and PGA outcomes. The report also reviews a supplemental BLA for self-administration via prefilled syringe and vial, supported by five-year safety and efficacy data from extension trials (T08, T09). Long-term safety data, including malignancy and infection rates, and immunogenicity/PK data up to year 5 are discussed. The document also addresses the Stelara REMS program, its proposed release, and subsequent decision to maintain it due to malignancy latency, alongside a medication error risk assessment. Meeting minutes confirm discussions on five-year data and self-administration.
Key findings — cited to the page
| Minimum body surface area involvement | 10 % | STUDY 1 and STUDY 2 · p.22 |
| Standardized incidence ratio (SIR) for malignancies (excluding NMSC) in ustekinumab subjects vs. general U.S. population | 0.98 | Global psoriasis studies · United States · p.71 |
| SIR for prostate cancer in ustekinumab subjects | 1.21 | Global psoriasis studies · United States · p.71 |
| SIR for melanoma (invasive and in situ) in ustekinumab subjects | 1.42 | Global psoriasis studies · United States · p.71 |
| SIR for colorectal cancer in ustekinumab subjects | 0.99 | Global psoriasis studies · United States · p.71 |
| SIR for breast cancer in ustekinumab subjects | 0.62 | Global psoriasis studies · United States · p.71 |
| Approval Date | May 21, 2013 | STELARA (ustekinumab) · United States · p.1 |
| Stelara (ustekinumab) self-administration approval in other jurisdictions | approved in several other jurisdictions, including the European Union, Canada and Australia, since 2009 | Stelara · EU, Canada, Australia · p.51 |
| PASI 75 response rate | 67 % | STUDY 1 · p.22 |
| PASI 75 response rate | 66 % | STUDY 1 · p.22 |
| PASI 75 response rate | 4 % | STUDY 2 · p.22 |
| Minimum PASI score | 12 | STUDY 1 and STUDY 2 · p.22 |
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 →