4th adaptive! Pfizer Xeljanz approved by FDA as the first JAK inhibitor for the treatment of early-onset idiolytic arthritis (JIA)!

September 29, 2020 // -- Pfizer (Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) has approved Xeljanz (Tofacitinib, Tofatinib) for the treatment of active polyarthritis (PCJIA) in children and adolescents as young as ≥2 years of age.
approval includes two dosage forms of Xeljanz, one tablet and the other oral solution, based on weight.
it's worth noting that this approval is Xeljanz's fourth indication, and the drug is the first and only JAK inhibitor approved in the U.S. for the treatment of pcJIA.
Xeljanz oral solution is expected to be available by the end of the first quarter of 2021.
Xeljanz 5 mg tablet will be available immediately.
"pcJIA is a debilitating disease because it can cause severe joint pain and limit children's participation in child-appropriate activities," said Dr. Hermine Brunner, director of rheumatology at Cincinnati Children's Hospital Medical Center and scientific director of the Children's Rheumatology Collaborative Research Group.
although several advanced treatments are available, the drug will be an attractive new option because Xeljanz does not require injections or infusions.
pcJIA is a considerable burden on patients and their guardians.
the FDA's approval of Xeljanz for pcJIA treatment is positive news because the drug offers a new advanced treatment option with an oral preparation.
Michael Corbo, chief development officer for inflammation and immunology at Pfizer Global Product Development, said: "Many children and adolescents with pcJIA require advanced oral treatment options, so we are proud to now offer Xeljanz to this patient group.
this approval is Xeljanz's fourth adaptive disorder, enhancing its effectiveness in treating immuno-mediated inflammatory diseases and further demonstrating our expertise in JAK science.
" new adaptation approval, based on the results of a Phase 3 study, consisted of two treatment periods: an 18-week open label, an import period (including 225 patients), followed by a 26-week double-blind, placebo-controlled, random, withdrawal period (including 173 patients) with a total duration of 44 weeks.
the study assessed the efficacy and safety of Xeljanz as a 5mg tablet or as an oral solution of 1mg/mL (weight <40 kg in patients taking oral solution) twice a day, as well as the patient's preferences.
results showed that the study reached the main endpoint: the proportion of patients who achieved JIA ACR30 remission at the end of the import period was statistically significantly reduced in the placebo group (55%, n/N=47/85), and in the Xeljanz group (31%, n/N=27/88) with a significant decrease in the proportion of patients with disease flares (acute exacerbation) (p=0.0007).
study, disease flares were defined as at least three of the six variables in the JIA ACR core set deteriorated ≥30 percent, and none of the remaining JIA core mitigation variables improved by ≥30 percent).
, the type of adverse drug reactions in pcJIA patients was consistent with the type of adverse drug reactions in patients with rheumatoid arthritis (RA).
Xeljanz's active pharmaceutical ingredient is tofacitinib (Tofacitinib), an oral JAK inhibitor that selectively inhibits JAK kinases and blocks the JAK/STAT path, a signaling path path that has been discovered in recent years to signal transductivity by cytokines, involving many important biological processes such as cell proliferation, differentiation, apoptosis, and immunomodulation.
the U.S., Xeljanz was approved in 2012 as the first JAK inhibitor to go on sale, taking the drug or mouth twice a day.
, Xeljanz had been approved for three adaptive disorders: (1) treatment of moderate to severe active rheumatoid arthritis (RA) ;(2) treatment of active psoriasis arthritis (PsA) ;(3) treatment of moderate to severe ulcerative colitis (UC).
the Chinese market, Xeljanz was approved in March 2017 for the treatment of moderate to severely active RA adult patients who are undertreated or insatiable with MTX treatment.
Xeljanz can be combined with MTX or other non-biological DMARD drugs, the recommended dose approved is 5 mg, 2 times a day or so, with or without food.
this approval, Xeljanz became the first JAK inhibitor to treat rheumatoid arthritis (RA) in the Chinese market.
() Origin: U.S. FDA appROVES PFIZER'S XELJANZ? (TOFACITINIB) FOR THE TREATMENT OF ACTIVE POLYARTICULAR COURSE PROCESS IDIOPATHIC ARTHRITIS.