CHMP rejects Xeljanz (Pfizer) as a treatment for Rheumatoid Arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for Xeljanz (tofacitinib citrate) for the treatment of adult patients with moderate-to-severe active Rheumatoid Arthritis. The CHMP is of the opinion that Xeljanz does not demonstrate a favorable risk:benefit profile at this time and recommended against marketing authorization.

Pfizer intends to appeal this opinion and immediately seek a re-examination of the opinion by the CHMP.

The Committee considered that treatment with Xeljanz resulted in an improvement in the signs and symptoms of Rheumatoid Arthritis and the physical function of patients, but did not believe that a consistent reduction in disease activity and structural damage to joints had been sufficiently demonstrated. The CHMP also raised questions about the serious infections, gastrointestinal perforations and malignancies observed in Xeljanz trials.