Pfizer has won US FDA approval for its rheumatoid arthritis (RA) therapy, Xeljanz (tofacitinib citrate) 5mg twice daily, indicated for patients who failed to respond to methotrexate.
Xeljanz can be used as a single treatment regime or as combination therapy with standard methotrexate or any non-biologic disease-modifying antirheumatic drugs (DMARDs).
Pfizer chairman and chief executive officer Ian Read said Xeljanz has the potential to change the way rheumatologists treat the serious autoimmune disease.
"With its novel mechanism of action, the discovery and development of XELJANZ by Pfizer scientists reflects our commitment to R&D innovation and our dedication to bringing important and meaningful medicines to patients," Read added.
The new oral DMARD RA therapy is designed to target specific signaling pathways called the JAK pathways that take part in causing inflammation associated with the disease.
Clinical studies were conducted to evaluate Xeljanz in both 5mg and 10mg twice-daily dosing regimens.
US regulator approved the 5mg twice-daily dose of the drug and specified the requirement of additional data to evaluate the 10mg twice-daily dose.
Pfizer specialty care and oncology president and general manager Geno Germano said, "In clinical trials, XELJANZ demonstrated consistent efficacy across a broad range of clinical measures and patient types, including patients who inadequately responded to non-biologic DMARDs and anti-TNF agents, and it has a safety profile that is well-characterized to date."
