European regulators will review Pfizer’s application to market Xeljanz 5mg twice daily for the treatment of patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
The application provides new information to the original submission for the drug, including data from the Phase III ORAL (Oral Rheumatoid Arthritis Phase III TriaLs) global development programme in RA - six completed clinical trials and two open-label long-term extension studies (one of which is still ongoing).
ORAL has accumulated more than 19,400 patient-years of drug exposure having been studied in more than 6,100 patients including follow-up observations of up to eight years in the LTE study, Pfizer noted.
“We are committed to making Xejanz (tofacitinib citrate) available to RA patients in the EU,” said Michael Corbo, category development lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business. “The up to eight years of data that we have accumulated demonstrate our commitment to understanding the efficacy and safety of Xeljanz in patients living with RA,” he noted.
Xeljanz is the only oral Janus kinase (JAK) inhibitor approved in more than 45 countries around the world for the treatment of moderate to severe RA, including the US, where it picked up its first regulatory green light in 2012.
But, in 2013, the European Medicines Agency’s the European Medicine Agency's Committee for Medicinal Products for Human Use did not recommend the drug's approval for RA, on grounds that it "did not believe that a consistent reduction in disease activity and structural damage to joints had been sufficiently demonstrated".