European Union Grants Marketing Authorization for Pfizer’s Xeljanz
Pfizer received European Commission approval for Xeljanz 5 mg twice-daily oral tablets, in combination with methotrexate, for rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.
The approval is based on a submission package that included results from a global Phase III development program and real-world data.
Xeljanz can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate. With the approval in the EU, Xeljanz is approved for use in more than 80 countries worldwide.