Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved XELJANZ (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight. This approval makes XELJANZ the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA.
Pfizer has several manufacturing facilities in Puerto Rico.
“Polyarticular course juvenile idiopathic arthritis, or pcJIA, is debilitating as it can cause significant jointpain 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. The FDA approval of Xeljanz for pcJIA is positive news for this community as it provides a new advanced treatment option in an oral formulation.”
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease of unknown etiology. JIA includes six categories: systemic, oligoarticular, polyarticular, enthesitis-related, psoriatic, and undifferentiated. Polyarticular JIA is characterized by arthritis in five or more joints and affects both the small joints of the hands and feet, and large joints like the knees, hips and ankles.
JIA is defined as arthritis that begins before 16 years of age and persists for at least six weeks. While its cause is unknown, approximately 300,000 children in the U.S. have a form of JIA.