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Pfizer's JAK Inhibitor Tofacitinib's Fifth Indication Approved

2023-01-31 10:00:00

Recently, Pfizer announced that the US FDA has approved the supplementary new drug application (sNDA) for the oral small molecule JAK inhibitor tofacitinib (tofacitinib, English trade name Xeljanz) for the treatment of one or more tumor necrosis Adult patients with active ankylosing spondylitis (AS) with insufficient response to factor (TNF) blockers or intolerance. .


AS is a chronic inflammatory disease, and symptoms usually occur before the age of 30. Symptoms of AS include back and hip pain and stiffness. Over time, some patients may experience spinal fusion. The disease can cause severe chronic pain to patients and negatively affect health-related quality of life.


Tofacitinib is a JAK inhibitor developed by Pfizer, which can effectively inhibit the activity of JAK1 and JAK3 and block the signal transduction of a variety of inflammatory cytokines. Previously, it has been approved by the FDA to treat four indications, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), adult patients with ulcerative colitis, and polyarticular juvenile idiopathic patients over 2 years old Patients with arthritis (pcJIA). Tofacitinib has been studied in more than 50 clinical trials worldwide.


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