Pfizer Inc. (PFE: Quote), the world's biggest drugmaker, said Tuesday that the U.S. Food and Drug Administration has approved Xeljang 5 mg twice daily for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Xeljang may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs.
Xeljang should not be used in combination with biologic disease-modifying antirheumatic drugs or potent immunosuppressives, such as azathioprine and cyclosporine.
Xeljang is approved as a second-line medicine for rheumatoid arthritis, which means treatment with a biologic is not required before taking Xeljang.
In the clinical trials, Xeljang was studied in both a 5 mg and 10 mg twice-daily dosing regimen. The FDA has approved the 5 mg twice-daily dose in the second-line setting and has indicated that further data are required to assess the benefit: risk profile of the 10 mg twice-daily dose.
Pfizer said it will continue to generate additional clinical data on the 10 mg twice-daily dose and work with the FDA to understand the additional data needed for further assessment of the 10 mg twice-daily dose.
FDA has approved Xeljang with a Risk Evaluation and Mitigation Strategy designed to healthcare providers and patients about the serious risks associated with Xeljang treatment.
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by RTT Staff Writer
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