Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA ® (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

HORSHAM, PA, April 24, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate. If approved for these indications, SIMPONI ARIA would be the first anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous infusion available for the treatment of these juvenile arthritides. Juvenile Idiopathic Arthritis (JIA) is a group of disorders characterized by arthritis persisting for at least six weeks before the age of 16 years.[i] Approximately 300,000 children suffer from some form of JIA in the United States.[ii] The polyarticular form of JIA is most common and is characterized by inflammation in more than four joints and resembles adult rheumatoid arthritis (RA).[iii] Juvenile psoriatic arthritis (PsA) is one of the rarest subtypes of JIA and is characterized by both joint inflammation and skin lesions associated with psoriasis resembling adult PsA.[iv],[v]“All forms of JIA can be debilitating for children who live with the disease, and their parents and physicians often have a difficult time establishing a treatment plan given the limited options currently available for pediatric ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news