JANSSEN BIOTECH — Tremfya FDA Review (NDA/BLA 761061, 2023)
Johnson & Johnson · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
Janssen Biotech's Tremfya (guselkumab) received FDA approval on July 13, 2020, for active psoriatic arthritis (PsA) in adults, expanding its existing plaque psoriasis indication. The recommended dosage is 100 mg subcutaneously at Week 0, Week 4, and every 8 weeks thereafter, usable alone or with DMARDs. This approval was based on two Phase 3 studies (PSA3001 and PSA3002) demonstrating significant efficacy over placebo across various endpoints, including ACR20/50/70, HAQ-DI, and dactylitis resolution. Guselkumab showed superiority over placebo and, in some cases, over adalimumab and ustekinumab in plaque psoriasis trials. The safety profile was consistent with known data, with most adverse events being mild and balanced across treatment groups. Clinical pharmacology indicated similar efficacy between 100 mg q8w and 100 mg q4w regimens, supporting the recommended dosing.
Key findings — cited to the page
| IGA score of 0 or 1 with a ≥2 grade improvement | 31 % | PsO3 · p.22 |
| IGA score of 0 or 1 with a ≥2 grade improvement | 14 % | PsO3 · p.22 |
| Grade 2 anemia (Study PSA3002) | 5 % | PSA3002 · p.161 |
| Grade 2 anemia (Study PSA3001) | 3 % | PSA3001 · p.161 |
| Grade 1 anemia (Study PSA3002) | 20 % | PSA3002 · p.161 |
| Grade 1 anemia (Study PSA3002) | 16 % | PSA3002 · p.161 |
| Grade 1 platelet count decrease (Study PSA3002) | 0.4 % | PSA3002 · p.162 |
| Grade 2 anemia (Study PSA3001) | 0.8 % | PSA3001 · p.161 |
| Grade 1 anemia (Study PSA3001) | 15 % | PSA3001 · p.161 |
| Grade 1 anemia (Study PSA3001) | 9 % | PSA3001 · p.161 |
| Grade 1 anemia (Study PSA3002) | 25 % | PSA3002 · p.161 |
| Grade 2 anemia (Study PSA3002) | 2 % | PSA3002 · p.161 |
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 →