Pfizer's oral JAK inhibitor Xeljanz receives two new indications in the EU

CompilationTom Lee

A few days ago, the European Commission (EC) announced the approval of Pfizer’s JAK inhibitor oral drug Xeljanz (tofacitinib) for the treatment of young children with active polyarticular joints who are two years of age and older who have first used anti-rheumatic drugs (DMARDs) and have poor response to treatment.
Patients with idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA)
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This time the European Union has approved two formulations of Pfizer Xeljanz, including a tablet and a new oral solution (the dosage is determined based on the weight of the patient)
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The active pharmaceutical ingredient of Xeljanz is tofacitinib, which is an oral JAK inhibitor that can selectively inhibit JAK kinase and block the JAK/STAT pathway.
This signaling pathway is a cytokine-stimulated pathway discovered in recent years.
The signal transduction pathway is involved in many important biological processes such as cell proliferation, differentiation, apoptosis and immune regulation
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In September 2020, the US FDA approved Pfizer Xeljanz for the treatment of juvenile idiopathic arthritis (pcJIA) in children and adolescents aged 2 years and older with active polyarticular disease
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It is worth noting that Xeljanz was approved for marketing in Mainland China in March 2017 for the treatment of moderate to severely active RA adult patients with insufficient or intolerable MTX treatment
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Although the drug has been approved by the European Union again this time, the potential safety issues of JAK inhibitors including Pfizer Xeljanz have always been the focus of attention of various countries
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Reference source: Xeljanz® (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis