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Pfizer’s Xeljanz recommended for EU approval as rheumatoid arthritis therapy
Pfizer's drug Xeljanz has been recommended for approval by the European Medicines Agency (EMA) as a treatment for rheumatoid arthritis.
The EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending Xeljanz for the treatment of moderate to severely active rheumatoid arthritis, in combination with methotrexate.
If approved by the European Commission, it will be indicated for use among adult patients who have responded inadequately to, or who are intolerant of, one or more disease-modifying antirheumatic drugs.
This recommendation was supported by data from the ORAL clinical trial programme, which consisted of six completed clinical trials, plus two open-label long-term extension studies, which accumulated more than 19,000 patient-years of drug exposure across more than 6,100 patients.
Michael Corbo, chief development officer for global inflammation and immunology product development at Pfizer, said: "The positive CHMP opinion for tofacitinib is an important milestone as we work to bring this new oral treatment option to people in the European Union living with moderate to severe active rheumatoid arthritis."
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