Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Xeljanz (tofacitinib) to treat children and adolescents two years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
Xeljanz, claimed to be the first and only Janus kinase (JAK) inhibitor approved in the US to treat pcJIA, is available in two formulations such as a tablet and an oral for dosing based on weight.
The regulator has approved Xeljanz based on data from a phase 3 study, which included two phases – an 18-week open-label, run-in phase and a 26-week double-blind, placebo-controlled, randomised and withdrawal phase.
With a total duration of 44 weeks, the trial’s run-in phase recruited 225 patients and the withdrawal phase recruited 173 patients.
The study assessed the efficacy and safety of tofacitinib taken as either a 5mg tablet or as a 1mg/mL oral solution twice daily based on the subject’s body weight and patient preference.
According to the company, the trial achieved its primary endpoint demonstrating that 30% response at the end of the run-in phase and the occurrence of disease flare in patients treated with tofacitinib is lower than in patients treated with placebo at week 44.
The company is immediately offering Xeljanz 5mg tablets and plans to introduce Xeljanz oral solution in the first quarter of 2021.
Pfizer global product development inflammation and immunology chief development officer Michael Corbo said: “Many children and adolescents living with polyarticular course juvenile idiopathic arthritis, or pcJIA, are in need of advanced oral treatment options, so we are proud to now offer Xeljanz to this patient community.
“This approval, which is the fourth indication for Xeljanz, reinforces its utility in the treatment of immune-mediated inflammatory conditions and further demonstrates our expertise in JAK science.”
Pfizer secured the FDA approval for Xeljanz in four indications, including adults with moderately to severely active rheumatoid arthritis (RA) after methotrexate failure and adults with active psoriatic arthritis (PsA) after disease-modifying antirheumatic drug (DMARD) failure.
The indications also include adults with moderately to severely active ulcerative colitis (UC) after tumour necrosis factor inhibitor (TNFi) failure and the patients, as well as to treat patients two years of age or older with active pcJIA.
In July this year, the US government placed an order worth $1.95bn with Pfizer and BioNTech to procure 100 million doses of their BNT162 vaccine candidate for Covid-19.