Pfizer’s Xeljanz approved by the FDA for the treatment of children with arthritis

pharmafile | September 29, 2020 | News story | Manufacturing and Production  

The FDA has approved Pfizer’s Xeljanz (tofacitinib) for the treatment of children and adolescents with active polyarticular course juvenile idiopathic arthritis (pcJIA).

The therapy was approved in two formulations: a tablet and oral solution to treat those over two years old. The approval is the first treatment that uses a Janus kinase (JAK) inhibitor to be available in the US for the treatment of pcJIA.

The FDA approval was based on a Phase 3 study that included 173 patients being tested over 44 weeks to determine the efficacy and safety of the drug. The study assessed patients taking either a 5mg tablet or 1mg oral solution versus a placebo.

The trial met its primary endpoint and showed that patients with pcJIA treated with the drug saw a significantly lower occurrence of disease flare ups compared to patients treated with placebo.

Michael Corbo, Chief Development Officer, Inflammation & Immunology at Pfizer, 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.”

pcJIA is a form of arthritis that usually begins before 16 years of age and persists for at least six weeks. 300,000 children in the US have a form of JIA. Xeljanz has already been approved in the US for multiple conditions associated with arthritis.

Conor Kavanagh

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