PF PRISM CV — Xeljanz FDA Review (NDA/BLA 203214, 2019)
PF PRISM CV · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib) 5 mg tablets, submitted by Pfizer, Inc. Approved in February 2015, the sNDA primarily focused on modifying the Xeljanz Risk Evaluation and Mitigation Strategy (REMS). The key change, approved in December 2014, was the removal of the Medication Guide as a mandatory REMS element to reduce healthcare burden, while retaining it in the approved labeling. The REMS goal was also adjusted to no longer include patients, as prior assessments showed adequate patient understanding. The document consistently highlights serious risks associated with Xeljanz, including infections, malignancies, and laboratory abnormalities.
Key findings — cited to the page
| REMS modification approval date | March 26, 2014 | · p.31 |
| 18-month REMS Assessment Report submission date | May 5, 2014 | · p.31 |
| Indication | treatment of adult patients with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate | Xeljanz (Tofacitinib) · United States · p.1 |
| Xeljanz approval date | November 6, 2012 | · p.30 |
| REMS original approval date | 11/06/2012 | Xeljanz (tofacitinib) · United States · p.4 |
| Approval Date | 02/11/2015 | Xeljanz (Tofacitinib) · United States · p.1 |
| sNDA Approval Date | 02/11/2015 | Xeljanz (tofacitinib) · United States · p.4 |
| REMS modification approval date | 11/08/2013 | Xeljanz (tofacitinib) · United States · p.4 |
| REMS modification approval date | 03/26/2014 | Xeljanz (tofacitinib) · United States · p.4 |
| REMS modification approval date | November 8, 2013 | · p.31 |
| REMS most recent modification date | February/2015 | Xeljanz (Tofacitinib) · United States · p.8 |
| REMS Modification Notification Letter date | September 9, 2014 | · p.31 |
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 →