Pfizer Inc. — Xeljanz FDA Review (NDA213082, ORIG 1, 2020)
Pfizer Inc. · 2020 · FDA Review (openFDA) · company profile →
Report summary
The FDA reviewed Pfizer's Xeljanz (tofacitinib) for polyarticular course juvenile idiopathic arthritis (pcJIA) in patients aged 2 years and older, covering both oral tablet and solution formulations. The application fulfilled post-marketing pediatric study requirements. The pivotal Phase 3 study A3921104 demonstrated Xeljanz's efficacy in reducing disease flares compared to placebo, with a safety profile consistent with adult rheumatoid arthritis patients, primarily involving increased infection risk. While the benefit-risk profile was deemed favorable, long-term safety, particularly regarding bone growth, infections, malignancies, and thrombosis, requires ongoing postmarketing monitoring. Dosing strategies align pediatric exposure with adult regimens, with adjustments for renal/hepatic impairment. The Childhood Health Assessment Questionnaire (CHAQ) Disability Index was deemed insufficient as a primary outcome measure.
Key findings — cited to the page
| NDA/BLA number | 213082 | XELJANZ / Tofacitinib Oral Solution · p.28 |
| NDA submission date | March 26, 2020 | XELJANZ (tofacitinib) IR tablet (5 mg) and tofacitinib oral solution (1 mg/mL) · p.36 |
| Applicant | Pfizer Inc. | · p.2 |
| NDA/BLA number | 203214 S-026 | XELJANZ / Tofacitinib Tablet · p.28 |
| Request for Agency Feedback submission date | 18 June 2018 | · p.28 |
| Meeting request submission date | 31 July 2019 | · p.28 |
| Application Number | 213082Orig1s000 | Xeljanz FDA Review · p.1 |
| NDA Application Number | 213082 | XELJANZ / Tofacitinib Oral Solution · p.2 |
| PMR 1934-1 requirement | A multiple-dose pharmacokinetic trial in children from 2 to less than 18 years of age with juvenile idiopathic arthritis (JIA) | · p.14 |
| PMR 1934-2 requirement | A randomized withdrawal, double-blind, placebo-controlled trial to evaluate the efficacy and safety of tofacitinib in children from 2 to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis. | · p.14 |
| Protocol amendment submission date | 18 March 2016 | · p.28 |
| Nervous system disorders (SAEs) | 2 | pcJIA clinical program · p.80 |
Source: Pfizer 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 →