Pfizer announced that the FDA has approved Xeljanz (tofacitinib citrate) tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had inadequate response or intolerance to methotrexate.  Xeljanz may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDS).

Results from clinical trials showed that Xeljanz demonstrate consistent efficacy across a broad range of clinical measures and patient types, including patients who inadequately responded to non-biologic DMARDs and anti-TNF agents, and it has a safety profile that is well-characterized to date.

Xeljanz inhibits the Janus kinase (JAK) pathway, a signaling pathway inside the cell that plays an important role in the inflammation involved in RA. Xeljanz was approved as a second-line treatment for RA, which means treatment with a biologic is not required before taking Xeljanz.

The FDA has approved Xeljanz 5mg with a Risk Evaluation and Mitigation Strategy (REMS) designed to inform healthcare providers and patients about the serious risks associated with treatment. The FDA stated that further data are required to assess the benefit-to-risk profile of the 10mg dose.  

Xeljanz is expected to be available towards the end of November.

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