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Xeljanz (Tofacitinib Citrate) Gets FDA Nod for Rheumatoid Arthritis

First new oral DMARD for RA in more than 10 years (Nov. 6)

The FDA has approved Xeljanz (tofacitinib citrate, Pfizer) 5 mg twice daily for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or are intolerant of methotrexate.

Xeljanz may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). Xeljanz should not be used in combination with biologic DMARDs or potent immunosuppressives, such as azathioprine and cyclosporine.

Xeljanz is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors and the first new oral DMARD for RA in more than 10 years. The drug is approved as a second-line medicine for RA, which means that treatment with a biologic is not required before taking Xeljanz.

Xeljanz is designed to inhibit JAK signaling pathways inside cells, which play an important role in the inflammation involved in RA. The global clinical development program for Xeljanz evaluated approximately 5,000 RA patients.

Adverse events associated with Xeljanz include serious infections, such as tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforation; decreased neutrophil and lymphocyte counts; decreased hemoglobin; elevated liver enzymes elevations; and lipid elevations.

In clinical trials, Xeljanz was studied in both 5-mg and 10-mg twice-daily dosing regimens. The FDA has approved the 5-mg twice-daily dosage 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 dosage.

The FDA might also assess the inhibition of structural joint damage with Xeljanz. In this regard, the manufacturer plans to discuss with the agency the submission of results from the ORAL Start (A3921069) study, which demonstrated the efficacy of Xeljanz monotherapy versus methotrexate, including inhibiting structural damage. The ORAL Start study was ongoing at the time of the New Drug Application submission for Xeljanz and was not included in the original application to the FDA.

The agency has approved Xeljanz with a Risk Evaluation and Mitigation Strategy (REMS) designed to inform healthcare providers and patients about the serious risks associated with Xeljanz therapy.

Source: Pfizer; November 6, 2012.

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