The US Food and Drug Administration (FDA) has accepted Pfizer’s new drug application (NDA) for Xeljanz (tofacitinib citrate) 11-mg, once-daily, modified-release tablets for treating moderate to severe rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in February 2016 for the NDA.

Xeljanz an inhibitor of Janus kinases (JAKs) indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs. The drug was first approved in the US in 2012 in 5-mg twice daily and is now approved in 40 countries for moderate to severe rheumatoid arthritis (RA). In the United States, XELJANZ has a boxed warning for serious infections and malignancies.

The NDA now under review is for a new dosing of the drug. A supplemental NDA for Xeljanz 10 mg and 5 mg tablets twice daily is currently under review with the FDA for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Source: Pfizer