5 July 2018 - - New York, New York-based biopharmaceutical and healthcare products specialist Pfizer Inc. (NYSE: PFE) has received European Commission (EC) approval of Xeljanz (tofacitinib citrate) 5 mg twice daily in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy, the company said.
The EC approval was based on a submission package that included data from the phase 3 oral psoriatic arthritis trials (OPAL) clinical development program, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance.
Xeljanz (tofacitinib citrate) is a Janus kinase inhibitor already approved by the US FDA for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
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