Posted by Michael Wonder on 28 Jun 2018
Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for active psoriatic arthritis
28 June 2018 - Pfizer announced today that the European Commission has approved 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 anti-rheumatic drug therapy.
Xeljanz is the first and only oral Janus kinase inhibitor to be approved in the European Union (EU) for the treatment of adults with active psoriatic arthritis (PsA). In 2017, Xeljanz in combination with methotrexate was approved in the EU for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug.
The EC approval was based on a submission package that included data from the Phase 3 Oral Psoriatic Arthritis TriaLs (OPAL) clinical development program in PsA, 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.
