XELJANZ Receives EU Marketing Authorization for Adults with Active PsA

Monday, July 02, 2018 | FDA Approval/Clearance , Phase 3/4 Trials , Psoriasis , Pfizer


The European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

XELJANZ is the first and only oral Janus kinase (JAK) inhibitor to be approved in the European Union (EU) for the treatment of adults with active PsA. In 2017, XELJANZ in combination with MTX 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 DMARDs.

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.

“Psoriatic arthritis, a chronic inflammatory condition which affects between 1.5 and 3 million people in Europe, causes joint pain and swelling that can eventually lead to permanent joint damage if not diagnosed and treated sufficiently early on,” says Frank Behrens, Rheumatology at Goethe University and Fraunhofer IME-Translational Medicine & Pharmacology, Frankfurt, Germany, in a news release. “This approval for XELJANZ is an important milestone for the psoriatic arthritis community, who are in need of an additional oral treatment option to help manage their condition.”

 

 

Next Story

Comments

You must be logged in to leave a comment.