Disappointment for Pfizer on negative CHMP view for Xeljanz

26 July 2013

There was disappointment for US pharma behemoth Pfizer (NNYSE: PFE), when the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has confirmed its earlier opinion to recommend against approval of Xeljanz (tofacitinib citrate) for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA; The Pharma Letter April 26).

After re-examination of the application as requested by Pfizer, the CHMP is of the opinion that Xeljanz does not demonstrate a favorable benefit:risk profile. The drug is already approved by the US Food and drug Administration (The Pharma Letter November 7, 2012) and has also been cleared for marketing in Japan and Russia.

Outstanding issues on safety

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