The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Pfizer’s Xeljanz (tofacitinib citrate) 5 mg twice daily for the treatment of patients with moderate to severe active rheumatoid arthritis (RA).
Next step is to European Commission (EC) make final decision. If approved, Xeljanz in combination with methotrexate (MTX) will be indicated for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate, Pfizer explained in its press release on Friday.
“More than 2.9 million people are currently living with moderate to severe rheumatoid arthritis in Europe. Even with multiple therapeutic options, many of these people may not adequately respond to currently available treatments, including methotrexate,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development.