Pfizer XELJANZ, used for juvenile idexual arthritis, has been approved for a fourth allergy in the United States.

On September 28, Pfizer announced that the U.S. FDA has approved XELJANZ® (Tofacitinib, Tofacitinib) for the treatment of adolescent idiopathic arthritis (pcJIA) in children and adolescents 2 years of age and older.
approved two formulations, one tablet and the other oral solution, which needs to be given according to the patient's weight.
said the XELJANZ oral liquid version is expected to be available by the end of the first quarter of 2021, while 5 mg tablets will be available immediately.
this approval makes XELJANZ the first and only Janus kinase (JAK) inhibitor approved for the treatment of pcJIA in the United States.
's approval was based on data from a Phase 3 study, A3921104, which consisted of two phases: an 18-week open label, an operational phase study (including 225 patients), followed by a 26-week double-blind, placebo-controlled, randomized, drug-stopping phase study (including 173 patients) with a total duration of 44 weeks.
the study was conducted to assess the efficacy and safety of both dosage forms by arranging treatment with tofatinib 5 mg tablets or 1 mg/mL oral solution based on the subject's weight (-lt;40 kg given oral solution) and/or patient characteristics.
results showed that the trial reached its main endpoint, i.e. at the end of the 18-week operational phase study, pcJIA patients treated with tofatinib achieved a 30 response (improvement of more than 30%) from the JIA American Rheumatology Society (ACR); The rate of onset of the disease in patients treated with tofatinib was 31% (n/n=27/88), significantly lower than in the placebo group (55%, n/n=47/85; p=0.0007).
disease attacks are defined as at least three of the six variables set by the JIA ACR core that have deteriorated by 30% or more, while after random grouping, no more than one of the remaining JIA core response variables has improved by 30% or more (the result indicator used in JIA clinical trials).
in addition, in the study, the type of adverse drug reactions in patients treated with tofatinib in pcJIA was consistent with the type of adverse drug reactions in patients with rheumatoid arthritis (RA).
common adverse reactions include diarrhea, headaches, and high blood pressure;
the European Medicines Agency's safety committee began a review of tofatiniini in 2019 and advised doctors not to give twice-daily doses of 10 mg to people at high risk of pulmonary embolism.
FDA has also issued warnings about the risk of blood clots caused by the drug.
XELJANZ® is an inhibitor of janus kinase 1 (JAK1) and janus kinase 3 (JAK 3), which means it interferes with the JAK-STAT signaling path, which transmits extracellular information to the nucleus, affecting DNA transcription.
in established mouse models of arthritis, tofatiniry rapidly improved inflammatory disease by inhibiting the production of inflammatory media and inhibiting STAT1-dependent genes in joint tissue.
researchers believe that the efficacy in this disease model is related to the suppression of JAK1 and JAK3 signaling path paths, suggesting that tofatini is likely to play a therapeutic role by non-separate inhibition of JAK3.
, XELJANZ has conducted more than 50 clinical studies and more than 20 RA trials worldwide over the past seven years.
Previously, XELJANZ® has been approved in the United States for three adaptive disorders, namely, for the treatment of moderate to severe active RA patients after the failure of methotrexate;
source: 1. Wikipedia 2.U.S. FDA Approveds Pfizer's XELJANZ® (tofacitinib) for The Treatment of Active Polyarticular Course Idpathic Arthritis.