Pfizer says negative CHMP opinion for Xeljanz

Pfizer Inc. (NYSE:PFE) said EMA's CHMP recommended against approval of an MAA for Xeljanz tofacitinib to treat moderate to severe rheumatoid arthritis. According to Pfizer, the committee said that while Xeljanz improved the signs and symptoms of RA and patients' physical functions, CHMP "did not believe that a consistent reduction in disease activity and structural damage had been sufficiently demonstrated." The pharma said the committee also expressed concern about serious infections, gastrointestinal perforations and malignancies in clinical trials of the oral pan-Janus kinase (JAK) inhibitor. Pfizer said it plans to appeal and seek a re-examination of the opinion. The MAA included data for both a 5 and 10 mg dose of Xeljanz. ...