Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for Pfizer’s Xeljanz for treatment of rheumatoid arthritis (RA).
According to the CHMP, Xeljanz does not currently demonstrate a favorable risk:benefit profile, and therefore is not recommended for marketing authorization. Xeljanz is for treatment of adult patients with moderate-to-severe active RA. The Committee believes that the drug improved patients’ signs and symptoms of rheumatoid arthritis and the physical function of patients, but do not believe that the drug demonstrated a consistent reduction in disease activity and structural damage to joints. Additionally, the Committee raised concern over the serious infections, gastrointestinal perforations, and malignancies that were observed in trials evaluating the drug.
Data from the comprehensive, global, multi-study clinical development program for Xeljanz was included in the Marketing Authorization Application (MAA). Data from studies included 5,000 patients across Phase 2 and 3 trials in over 40 countries. Xeljanz is currently approved in the US, Japan and Russia for this indication.
“We have confidence in Xeljanz and believe our application to the EMA demonstrates that Xeljanz has a favorable risk:benefit profile. Xeljanz’s safety profile is well-characterized, and the issues raised by the EMA, including serious infections, gastrointestinal perforations and malignancies, are familiar to rheumatologists who are experienced working with treatments for patients to manage this difficult disease,” Dr. Yvonne Greenstreet, Senior Vice President and the Head of the Medicines Development Group for Pfizer Specialty Care stated. “Each regulatory authority will interpret applications individually and different assessments are not uncommon. The re-examination process will enable us to seek to address the CHMP’s questions, and we will continue to work closely with the EMA with the goal of making this medicine available to appropriate patients in Europe.”
Source: Pfizer Inc.
Last Updated: 4/26/13; 10:10AM EST