CHMP confirms rejection of Xeljanz for RA
Pfizer Inc. announced 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 favourable 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.
Pfizer is currently evaluating the feedback from the CHMP and will determine next steps to resubmit a MAA to the EMA.
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