Approvals and launch update for XELJANZ® (tofacitinib citrate)

Pfizer Inc. (NYSE: PFE) announced today that tofacitinib has been approved for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to existing therapies in several additional countries around the world, including Switzerland, which is the first European country to receive approval. Swissmedic, the Swiss agency for therapeutic products, approved tofacitinib 5 and 10 mg twice-daily (BID) as monotherapy or in combination with a disease modifying non-biologic antirheumatic agent (DMARD), including methotrexate (MTX), in adult patients with moderate-to-severe active RA who have had an inadequate response or intolerance to MTX.  Tofacitinib 5 mg BID has also been approved in Argentina, Kuwait and the United Arab Emirates, and tofacitinib 5 mg and 10 mg BID has been approved in Russia. The brand name for tofacitinib in the approved markets will be XELJANZ, except for Russia, where the brand name will be Jaquinus^®.

As previously announced, XELJANZ 5 mg BID is also approved in the United States and Japan for the treatment of moderate-to-severe active RA. XELJANZ was launched in the United States in November 2012, and XELJANZ is expected to be commercially available in Japan this month following approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) in March 2013. XELJANZ will be co-promoted in Japan by Pfizer and Takeda Pharmaceutical Company Limited. Initially, XELJANZ will be made available in Japan to medical institutions participating in an all-patient surveillance program, designed by Pfizer in collaboration with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the Japan College of Rheumatology. 

“More than 23 million people worldwide are living with rheumatoid arthritis and there remains an unmet need for additional treatments, with up to one-third of RA patients not adequately responding and about half who stop responding to any particular DMARD within five years,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer. “XELJANZ has a novel mechanism of action for the treatment of moderate-to-severe RA. With these approvals, 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.”

Regulatory applications for XELJANZ for the treatment of moderate-to-severe active RA remain under review in more than 30 additional countries. In Europe, Pfizer is seeking a re-examination of the Committee for Medicinal Products for Human Use (CHMP) negative opinion that was announced in April, and the company is currently working with the CHMP on the next steps in the process.

XELJANZ is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. The recent marketing authorizations for XELJANZ were based on data from the comprehensive, global, multi-study clinical development program for XELJANZ, which included approximately 5,000 patients in more than 40 countries, resulting in 7,000 patient-years of experience at the time of regulatory submission.