The United States Food and Drug Administration (FDA) accepted for review Pfizer’s new drug application (NDA) for Xeljanz (tofacitinib citrate) 11 mg once daily modified release tablets 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 Xeljanz 11 mg once daily modified release is based on data from a clinical pharmacology programme designed to demonstrate equivalence in key pharmacokinetic parameters to Xeljanz 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.”

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

Pfizer is committed to building on the science and understanding of JAK inhibition and Xeljanz through a robust clinical development programme in a range of immune-mediated inflammatory conditions in the areas of rheumatology, dermatology and gastroenterology. A supplemental new drug application 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. The benefit: risk profile of Xeljanz in RA has been studied in approximately 6,200 patients in the global clinical development program for Xeljanz in moderate to severe RA.

Xeljanz is a prescription medicine called a Janus kinase (JAK) inhibitor. The recommended dose is 5 mg twice-daily (BID). Xeljanz is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. Xeljanz may be used as a single agent or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of Xeljanz in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine is not recommended.

It is not known if Xeljanz is safe and effective in people with hepatitis B or C; Xeljanz is not for people with severe liver problems; It is not known if Xeljanz is safe and effective in children.