EMA Accepts Pfizer’s MAA for Rheumatoid Arthritis DrugBy
The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for Pfizer’s Xejanz (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). The EMA will now initiate its review of the drug.
Xejanz is a Janus kinase (JAK) inhibitor and is approved in more than 45 countries for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs.
Pfizer has also developed an extended-release formulation, Xejanz XR 11 mg, an once-daily oral JAK inhibitor for the treatment of moderate to severe RA, approved in the United States.