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FSA accepts for review NDA for a once daily formulation of Xeljanz modified release tablets

3 July 2015  •  Author: Victoria White

The US Food and Drug Administration (FDA) has accepted for review Pfizer’s new drug application (NDA) for Xeljanz for the treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).


The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in February 2016 for the NDA.

The NDA for Xeljanx 11 mg once daily modified release is based on data from a clinical pharmacology programme designed to demonstrate equivalence in key pharmacokinetic parameters to Xeljanx 5 mg twice daily.

“This filing underscores our commitment to helping advance patient care and our goal of providing innovative solutions for patients with RA,” said Rory O’Connor, MD, senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc. “If approved, it would bring us one step closer to offering the first and only once-daily oral Janus kinase inhibitor treatment for those living with moderate to severe RA who have had an inadequate response or intolerance to methotrexate.”

Xeljanx is approved in 40 countries for the treatment of moderate to severe RA

As the developer of Xeljanx, Pfizer is a leader in the research of this new class of medications. Xeljanx is approved in 40 countries around the world for the treatment of moderate to severe RA. In the United States, Xeljanx has a boxed warning for serious infections and malignancies.

A supplemental new drug application for Xeljanx 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. The benefit:risk profile of Xeljanx in RA has been studied in approximately 6,200 patients in the global clinical development programme for Xeljanx in moderate to severe RA.

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