Pfizer's tofacitinib meets Ph III endpoints in patients with active RA

Global drugs behemoth Pfizer (NYSE:PFE) says that tofacitinib (development code: CP-690,550), an investigational, novel, oral JAK inhibitor being studied in moderate-to-severe rheumatoid arthritis (RA), met its primary endpoints in the ORAL Sync (A3921046) Phase III study.

The drug, formerly known as tasocitinib, showed statistically-significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4(ESR) <2.6 at six months.

The safety profile of tofacitinib was consistent with that seen previously in the clinical program, and no new safety signal was detected. A full analysis of efficacy and safety data will be submitted to a future scientific meeting, said Pfizer, which is facing significant sales erosion as its all-time best-selling cholesterol lowerer Lipitor (atorvastatin) faces patent loses in November.

$2 billion sales potential