Pfizer has suffered a major setback after advisors to the European Medicines Agency again rejected Xeljanz for rheumatoid arthritis.
The agency’s Committee for Medicinal Products for Human Use has confirmed a negative opinion made in April to recommend against approval of Xeljanz(tofacitinib) for the treatment of adults with moderate-to-severe active RA. After re-examination of the application as requested by Pfizer, the CHMP believes the drug does not demonstrate a favourable benefit/risk profile.
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, Pfizer notes, although it has “outstanding concerns on safety, including serious infections”.
The drugs giant is currently evaluating the feedback from the CHMP and will determine next steps to resubmit its application to the EMA. Steven Romano, head of the medicines development group for Pfizer Specialty Care, who said the firm is disappointed, claimed that “a narrow majority of the CHMP felt there is too limited experience in the patient population to fully characterize the profile of Xeljanz”.
He added that 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”. Dr Romano concluded by saying “we believe that the benefit/risk profile of Xeljanz is favourable, and we remain committed to working with the EMA”.
