PF PRISM CV — Xeljanz FDA Review (NDA/BLA 203214, 2022)
PF PRISM CV · 2022 · FDA Review (Drugs@FDA)
Report summary
This FDA approval package for XELJANZ (tofacitinib) details its approval for moderately to severely active ulcerative colitis, alongside existing indications for rheumatoid and psoriatic arthritis. The document outlines dosage, contraindications, and adverse reactions, emphasizing serious infections, malignancies, and gastrointestinal perforations as key safety concerns, often with dose-dependent risks. Efficacy data from clinical trials demonstrate XELJANZ's superiority over placebo in achieving remission and mucosal healing across indications. The report also covers pharmacokinetics, specific patient populations (pediatric, geriatric, pregnant), and postmarketing study requirements. Safety analyses highlight increased risks of Herpes Zoster, non-melanoma skin cancer, and other adverse events with higher doses. The review supports 10 mg BID for induction and 5 mg BID for maintenance in UC, with ongoing monitoring for long-term safety.
Key findings — cited to the page
| HZ infection incidence rate ratio (IRR) | 1.0 | · p.208 |
| Opportunistic infection incidence rate ratio (IRR) | 0.8 | · p.212 |
| NMSC incidence rate ratio (IRR) | 1.3 | · p.217 |
| Postmarketing study (PMR 3400-1) final report submission date | 09/2022 | XELJANZ (tofacitinib) in pediatric patients 2 to 17 years of age with moderately to severely active ulcerative colitis · p.6 |
| Pediatric study requirement waiver for ages | <2 years | · p.5 |
| Indication | treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). | XELJANZ · United States · p.1 |
| Pediatric study deferral for ages | 2 to 17 years | · p.5 |
| Indication | treatment of adult patients with moderately to severely active ulcerative colitis (UC). | XELJANZ · United States · p.1 |
| Supplemental New Drug Application (sNDA) approval for Ulcerative Colitis | approved | XELJANZ (tofacitinib) · United States · p.4 |
| Action for patients with ANC 500 to 1000 cells/mm3 | Interrupt dosing | XELJANZ/XELJANZ XR · p.17 |
| Approval Date | May 30, 2018 | XELJANZ · United States · p.1 |
| Indication | treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). | XELJANZ · United States · p.1 |
Source: PF PRISM CV ↗ · 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 →