Pfizer’s rheumatoid arthritis drug approved in Japan

Hannah Blake

pharmaphorum

Pfizer has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Xeljanz (tofacitinib citrate) for the treatment of adults with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies.

Xeljanz is the first approved oral treatment in a new class of medicines known as Janus kinase (JAK) inhibitors.

“RA is a serious and disabling disease and there is a need for new treatment options, as a significant number of patients do not adequately respond to current therapies. We are proud of our strong portfolio of treatments for inflammatory disorders in Japan, and we are pleased with the approval of XELJANZ, which allows us to offer an additional treatment option for RA patients.”

Mark Swindell, Head of Pfizer Specialty Care Business Unit in Japan.

A global clinical trial program evaluated Xeljanz in approximately 5000 patients across various RA patient populations. Across five global pivotal trials, Xeljanz 5 mg twice daily demonstrated efficacy, whether administered alone or in combination with a non-biologic DMARD, such as methotrexate, in patients who had a previous inadequate response to non-biologic or biologic DMARDs, including tumor necrosis factor (TNF) inhibitors.

Now it is approved, Xeljanz will be commercially available in Japan after the National Health Insurance listing and will be co-promoted in Japan by Pfizer and Takeda Pharmaceutical Company Limited.