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Switzerland becomes first European country to receive Xeljanz approval
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Tofacitinib has been approved as treatment for adults with rheumatoid arthritis in Switzerland, the first European country to receive approval of the novel, oral Janus kinase inhibitor, according to manufacturer Pfizer.
Swissmedic, the Swiss agency for therapeutic products, approved tofacitinib (Xeljanz) at 5 mg and 10 mg twice daily as monotherapy or in combination with a disease-modifying antirheumatic drug (DMARD), including methotrexate (MTX), in adults with rheumatoid arthritis (RA) previously intolerant to MTX, according to a press release.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended against marketing tofacitinib in April. Pfizer is seeking a re-examination of the recommendation and working with the committee on “the next steps of the process,” Pfizer announced.
The FDA approved tofacitinib at 5 mg twice daily in November 2012 for adults with moderate to severe active RA who had inadequate response or intolerance to MTX.
Pfizer announced that tofacitinib 5 mg twice daily also has been approved in Argentina, Kuwait and the United Arab Emirates, while the drug at 5 mg and 10 mg twice daily has been approved in Russia and marketed as Jaquinus. All other countries will market it as Xeljanz.
It is expected to be commercially available at 5 mg twice daily in Japan later this month, and will be co-promoted by Pfizer and Takeda Pharmaceutical Company, the release said.
“We believe Xeljanz has the potential to change the way rheumatologists treat this chronic, and potentially disabling disease, and we are proud to offer patients and physicians an additional treatment option,” Geno Germano, president and general manager, Specialty Care and Oncology for Pfizer, said in the release.