Pfizer re-files Xeljanz in Europe for rheumatoid arthritis
Pfizer has refiled its Xeljanz (tofacitinib) for rheumatoid arthritis in Europe, which the European Medicines Agency rejected three years ago because of safety concerns.
The drug, an oral Janus kinase inhibitor, gained approval in the US in 2012 and is now approved in 45 countries, but remains unavailable in Europe.
The EMA will now review the filing in patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Pfizer has provided additional information, including data from the phase 3 ORAL global development programme in RA. This consisted of six completed clinical trials, in addition to two open-label long-term extension studies, one of which is still ongoing.
Pfizer said the programme included more than 19,400 patient-years of drug exposure in more than 6,100 patients, including follow-up observations of up to eight years in the long-term study.
The EMA rejected Xeljanz in 2013 citing "major concerns" about its safety profile, saying there were significant and unresolved concerns about the risk and type of serious infections related to the drug's immunosuppressant action.
Safety concerns also included a risk of other severe side effects including certain cancers, gastro-intestinal perforations, liver damage and increased fat levels in the blood.
The EMA said at the time it was unclear that these risks could be managed successfully in medical practice.
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