The FINANCIAL -- Pfizer Inc. announced on July 2 that 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 program designed to demonstrate equivalence in key pharmacokinetic parameters to XELJANZ 5 mg twice daily, according to Pfizer.
“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.