Pfizer Inc. — Xeljanz EMA EPAR public assessment report (EMEA/H/C/004214, 2017)
Pfizer Inc. · 2017 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Pfizer's Xeljanz (tofacitinib) for moderate to severe active rheumatoid arthritis. Xeljanz, a selective JAK kinase inhibitor, was previously denied approval due to safety concerns. The current application seeks approval for use with methotrexate or as monotherapy. The report details regulatory advice, product quality, non-clinical pharmacology (including rapid absorption and efficacy in animal models), and toxicology (hematopoietic/immune system effects, lymphomas in monkeys). Clinical data highlight dose-dependent infection risks, efficacy in Phase III trials (ACR20/50/70, mTSS, HAQ-DI), and safety concerns including serious infections (herpes zoster), malignancies, and cardiovascular risks. While demonstrating efficacy in improving RA symptoms and function, the report emphasizes the need for risk minimization strategies and ongoing pharmacovigilance.
Key findings — cited to the page
| Treatment-related effects on female reproduction | 100 mg/kg/day | · p.30 |
| NOEC (Reproduction Test, Daphnia sp.) | 4.8 mg/L | · p.33 |
| Subjects with Grade 1 Anemia (All Tofa) | 24.1 % | · p.124 |
| Subjects with Grade 4 Anemia (Tofa 5 mg BID) | 0 | · p.124 |
| Subjects with Grade 3 Anemia (Tofa 10 mg BID) | <1.0 % | · p.124 |
| Subjects with Grade 4 Anemia (Tofa 10 mg BID) | 0 | · p.124 |
| Subjects with Grade 1 Anemia (Tofa 5 mg BID) | 22.3 % | · p.124 |
| Subjects with Grade 1 Anemia (Tofa 10 mg BID) | 23.4 % | · p.124 |
| Subjects with Grade 2 Anemia (Tofa 5 mg BID) | 4.1 % | · p.124 |
| Subjects with Grade 3 Anemia (Tofa 5 mg BID) | <1.0 % | · p.124 |
| Subjects with Grade 2 Anemia (Tofa 10 mg BID) | 4.0 % | · p.124 |
| Subjects with Grade 2 Anemia (All Tofa) | 4.3 % | · p.124 |
Source: Pfizer Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →