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EMA accepts marketing authorization application for tofacitinib citrate for review

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The European Medicines Agency has agreed to review the marketing authorization application for tofacitinib citrate as a treatment for patients with moderate to severe rheumatoid arthritis, according to a press release from Pfizer Inc.

The application includes information from six completed phase 3 clinical trials and two open-label, long-term extension trials with a total of 19,400 patient-years among more than 6,100 patients. The studies with tofacitinib citrate (Xeljanz, Pfizer Inc.), a Janus kinase inhibitor, in patients with rheumatoid arthritis (RA) include data for up to 8 years.

“We are committed to making Xeljanz available to RA patients in the [European Union] E.U. The up to 8 years of data that we have accumulated demonstrate our commitment to understanding the efficacy and safety of Xeljanz in patients living with RA,” Michael Corbo, category development lead of Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business, said in the release. “We look forward to working together with the EMA on its review.”

Reference:

www.pfizer.com