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CHMP Issues Positive Opinion for Xeljanz
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Today, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for Pfizer’s Xeljanz 5 mg twice daily oral medication for the treatment of moderate to severe active rheumatoid arthritis, according to a company release.
“More than 2.9 million people are currently living with moderate to severe rheumatoid arthritis in Europe,” Michael Corbo, chief development officer of Inflammation & Immunology and Global Product Development at Pfizer, said in the release. “The positive CHMP opinion for tofacitinib [Xeljanz, Pfizer] is an important milestone as we work to bring this new oral treatment option to people in the European Union living with moderate to severe active rheumatoid arthritis.”
The positive opinion will be sent to the European Commission for final decision. If approved, Xeljanz — a Janus kinase inhibitor — in combination with methotrexate will be indicated for adult patients who have responded inadequately to or who are intolerant to a disease-modifying antirheumatic drug. Xeljanz can also be administered as monotherapy if the patient is intolerant to methotrexate or when methotrexate treatment is inappropriate.
The marketing authorization application used data from the eight Oral Rheumatoid Arthritis phase 3 trials (ORAL) , which included over 19,000 patient-years of drug exposure, 6,100 patients and follow-up up to 8 years in one of the long-term studies.
Xeljanz has been approved in over 50 countries and was approved in the United States in 2012.
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