Pfizer Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of patients with moderate to severe active rheumatoid arthritis (RA).
The CHMP’s opinion will be sent to the European Commission (EC) for 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.
“More than 2.9 million people are 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.
The marketing authorisation application (MAA) included data from the Oral Rheumatoid Arthritis Phase 3 TriaLs (ORAL) global development program in RA. This program consisted of six completed clinical trials, ORAL Start, ORAL Solo, ORAL Standard, ORAL Sync, ORAL Scan, and ORAL Step, in addition to two open-label long-term extension (LTE) studies. At the time of the MAA submission, the ORAL development program had accumulated more than 19,000 patient-years of drug exposure in over 6,100 patients with follow-up observations of up to eight years in one of the LTE studies.