US regulators have approved an extended-release version of Pfizer’s Xeljanz for the treatment of rheumatoid arthritis (RA), giving patients access to the first once-daily, oral JAK inhibitor for the condition.
The US Food and Drug Administration has cleared the drug’s use for treatment of moderate to severe RA in patients who have had an inadequate response or intolerance to methotrexate.
Xeljanz (tofacitinib) is already approved in more than 45 countries around the world for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs.
The introduction of the first and only once-daily oral JAK inhibitor for the condition gives patients a new treatment option and “builds upon Pfizer’s tradition of developing patient-centered therapies,” said Michael Corbo, category development lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business.
