Extended-release tofacitinib approved by FDA for RA treatment
Pfizer announced an extended-release formulation of tofacitinib has been approved by the FDA for the treatment of moderate-to-severe rheumatoid arthritis, according to a company press release.
The product is a once-daily, 11-mg oral Janus kinase (JAK) inhibitor, indicated for patients with an inadequate response or with intolerance to methotrexate. The extended-release formulation of tofacitinib (Xeljanz XR, Pfizer) can be taken with or without concomitant methotrexate or other disease-modifying antirheumatic drugs.
“The availability of Xeljanz XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” Roy Fleischmann, MD, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and co-medical director of the Metroplex Clinical Research Center, said in a press release.
The FDA approved a 5-mg dose of tofacitinib in November 2012. According to the release, Xeljanz XR 11 mg administered once daily is pharmacokinetically equivalent to Xeljanz 5 mg administered twice daily.
As noted in the press release, tofacitinib has been studied in trials with over 6,200 patients amounting to more than 19,400 patient-years of drug exposure.