Pfizer Inc. (NYSE: PFE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its April 25, 2013, opinion to recommend against approval of XELJANZ ® (tofacitinib citrate) for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). After re-examination of the application as requested by Pfizer, the CHMP is of the opinion that XELJANZ does not demonstrate a favorable benefit:risk profile.
While the CHMP considered that treatment with XELJANZ resulted in reduction in the signs and symptoms of RA and improvement in the physical function of patients, it has outstanding concerns on safety, including serious infections.
The Company is currently evaluating the feedback from the CHMP and will determine next steps to resubmit a MAA to the EMA.
“We are disappointed in the outcome of the re-examination process. A narrow majority of the CHMP felt there is too limited experience in the patient population to fully characterize the profile of XELJANZ and the Committee did not recommend approval at this time,” said Dr. Steven Romano, senior vice president and the head of the Medicines Development Group for Pfizer Specialty Care. “The clinical experience with XELJANZ to date, which includes data from approximately 5,000 patients treated for RA, 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. We believe that the benefit:risk profile of XELJANZ is favorable, and we remain committed to working with the EMA to make XELJANZ available to appropriate patients in Europe.”About the Marketing Authorization Application The MAA included data from the comprehensive, global, multi-study clinical development program for XELJANZ, which included approximately 5,000 patients across Phase 2 and Phase 3 trials in more than 40 countries, resulting in 7,000 patient-years of exposure at the time of regulatory submission. The application was based on the same pivotal efficacy and safety data package that was provided to regulatory agencies around the world.