Johnson & Johnson — Tremfya FDA Review (BLA761061, ORIG 1, 2017)
Johnson & Johnson · 2017 · FDA Review (openFDA) · company profile →
Report summary
The FDA review of Johnson & Johnson's Tremfya (guselkumab) BLA 761061 recommends approval for treating adult patients with moderate-to-severe plaque psoriasis. Guselkumab, a fully human IgG1λ monoclonal antibody targeting IL-23p19, demonstrated superior efficacy over placebo and adalimumab in pivotal Phase 3 trials (VOYAGE 1 & 2), achieving IGA 0/1 and PASI 90 at Week 16. Nonclinical studies showed no significant adverse effects, including on fertility, at high doses. Clinical pharmacology supports the proposed dosing regimen (100 mg SC at Weeks 0, 4, then every 8 weeks). The safety profile, evaluated across multiple trials, identified common adverse reactions like upper respiratory infections and headaches. While serious adverse events (e.g., infections, malignancies, MACE) were monitored, no new safety signals were identified, and no clinically meaningful imbalance in cardiovascular events was observed. Immunogenicity generally did not impact efficacy or safety. Identified safety concerns are manageable through labeling and pharmacovigilance.
Key findings — cited to the page
| Trial 3003 major secondary endpoint IGA 0 or 1 with >=2-grade improvement at Week 28 p-value | 0.001 | Trial 3003 · p.131 |
| ss-IGA score of 0 or 1 with at least 2-grade improvement from baseline | 14 % | Trial 3001 · p.116 |
| ss-IGA score of 0 or 1 with at least 2-grade improvement from baseline | 81 % | Trial 3002 · p.116 |
| Trial 3003 major secondary endpoint IGA 0 or 1 with >=2-grade improvement at Week 28 (ustekinumab) | 14% | Trial 3003 · p.131 |
| Trial 3003 major secondary endpoint IGA 0 or 1 with >=2-grade improvement at Week 28 (guselkumab) | 31% | Trial 3003 · p.131 |
| ss-IGA score of 0 or 1 with at least 2-grade improvement from baseline | 11 % | Trial 3002 · p.116 |
| ss-IGA score of 0 or 1 with at least 2-grade improvement from baseline | 83 % | Trial 3001 · p.116 |
| Elevated ALT (CTCAE grade 3) | 2 subjects | · p.154 |
| Elevated sodium (CTCAE grade 3) | 5 subjects | · p.154 |
| CTCAE grade 3 hematology abnormalities | 2 reports | · p.154 |
| Hematology value consistent with CTCAE grade 3 | 0.2 % | · p.153 |
| Elevated AST (CTCAE grade 4) | 795 U/L | Trial 3001 · p.155 |
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 →