CHMP again rebuffs Pfizer's Xeljanz

Pfizer Inc. (NYSE:PFE) said EMA's CHMP again recommended against approval of an MAA for Xeljanz tofacitinib to treat moderate to severe rheumatoid arthritis. According to the pharma, a "narrow majority" of the committee said "there is too limited experience in the patient population to fully characterize" Xeljanz, and the committee also had "outstanding concerns on safety, including serious infections." Pfizer, which had requested a re-examination of CHMP's original negative opinion, said it is evaluating CHMP's feedback and will determine next steps to resubmit the MAA for the oral pan-Janus kinase (JAK) inhibitor (see BioCentury Extra, April 25). ...