FDA Approves Pfizer's Xeljanz Label Update
Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) to update its rheumatoid arthritis treatment Xeljanz 5 mg tablets’ label update. The update will include radiographic data from two Phase 3 studies, ORAL Scan (A3921044) and ORAL Start (A3921069).
Xeljanz (tofacitinib citrate) is a Janus Kinase (JAK) inhibitor. The drug is used to treat adult patients with moderately to severely active rheumatoid arthritis who failed to respond well to or are unable to tolerate methotrexate therapy. Xeljanz may be used as a single agent or in combination with MTX and other non-biologic disease-modifying antirheumatic drugs (DMARDs). The recommended dose is 5 mg twice daily. Using the drug in combination with biologic DMARDs or potent immunosuppressants like azathioprine and cyclosporine is not recommended.
The company advises patients and healthcare professionals to consider risks and benefits prior to using Xeljanz in patients with chronic or recurrent infection, as the drug has been observed to lower the ability of the immune system to fight infections. The drug may also increase the risk of certain cancers by directly affecting the immune system, with malignancies observed in clinical studies.
The new updated U.S. label will include the radiographic response data from ORAL Scan (Study IV) at 6 months and ORAL Start (Study VI) at 6 and 12 months. The two studies assessed the effect of XELJANZ on structural joint damage progression as measured by mean change from baseline in van der Heijde modified Total Sharp Score (mTSS) together with its components, erosion score and joint space narrowing (JSN) score. In addition, the proportion of patients with no radiographic progression (mTSS change from baseline less than or equal to 0) was also assessed in the trials.
Dr. Steven Romano, Global Medicines Development Lead for the Pfizer Global Innovative Pharmaceutical business, said, “Xeljanz is the first oral JAK inhibitor for moderately to severely active rheumatoid arthritis. The reduction of radiographic progression seen in ORAL Scan and ORAL Start represents a clinically meaningful outcome for patients.”