Pfizer snagged its fourth indication for the blockbuster medication tofacitinib (Xeljanz) for children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
Pfizer snagged its fourth indication for the blockbuster medication tofacitinib (Xeljanz) for children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
Xeljanz is already approved to treat adults with moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, adults with active psoriatic arthritis (PsA) after disease modifying anti-rheumatic drug (DMARD) failure, and adults with moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure.
Related: FDA adds warning to Xeljanz
Now, Xeljanz is the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA, Pfizer said in a press release.
The FDA approved 2 formulations of the medication: a tablet and an oral solution, which Pfizer expects be available by the end of the first quarter of 2021. However, the 5 mg. tablets are available immediately.
Related: Another RA drug starts testing to treat COVID-19
“Polyarticular course juvenile idiopathic arthritis, or pcJIA, is debilitating as it can cause significant joint pain and limit participation in child appropriate activities,” said Dr. Hermine Brunner, director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center and scientific director of the Pediatric Rheumatology Collaborative Study Group.
“Although there are already several advanced treatments available, tofacitinib will be an appealing new option given it does not require injections or infusions. These can be quite burdensome to both children with pcJIA and their caretakers,” Brunner said.
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