The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion for European marketing authorization of Pfizer's Xeljanz (tofacitinib citrate).
Xeljanz is a novel, oral Janus kinase (JAK) inhibitor for the treatment of RA, targeting the intracellular pathways.
The confirmation came after the re-examination of the application on Pfizer's request, which identified that Xeljanz fails to demonstrate a favorable benefit:risk profile.
CHMP considered that Xeljanz treatment leads to reduced signs and symptoms of rheumatoid arthritis (RA) and improvement in the physical function of patients.
Pfizer Specialty Care the Medicines Development Group senior vice president and the head Dr Steven Romano said the clinical experience with XELJANZ demonstrates a consistent efficacy and safety profile across a range of patient types and a risk profile that is familiar to rheumatologists who have experience utilizing the range of treatments available to treat this disease.
The company plans to work with the EMA to resubmit marketing authorization application.
