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Golimumab receives positive opinion from the CHMP for treatment of pJIA
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Janssen Biologics B.V. announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the use of subcutaneous golimumab in combination with methotrexate for the treatment of polyarticular juvenile idiopathic arthritis in children who had an inadequate response to methotrexate and weigh at least 40 kilograms.
According to a company press release, the opinion was based on a review of data from the phase 3 GO KIDS trial that evaluated the efficacy and safety of golimumab (Simponi, Janssen) in 173 children who had polyarticular juvenile idiopathic arthritis (pJIA), active arthritis in at least five joints and poor response to methotrexate. The European Commission is expected to make a final decision on the use of golimumab in the coming months. If approved, golimumab will become available for the treatment of patients with active pJIA.
“We commend the European Medicines Agency, the Pediatric Rheumatology International Trial Organization and the Pediatric Rheumatology Collaborative Study Group, for a concerted and collaborative review of data and supportive analyses from the Simponi phase 3 GO KIDS study to arrive at today’s positive opinion,” Newman Yeilding, MD, vice president and head of the Immunology Development at Janssen Research & Development LLC, said in the release. “We believe the totality of data from the GO KIDS study supports the efficacy and safety of Simponi in the treatment of polyarticular juvenile idiopathic arthritis and look forward to the European Commission’s decision.”
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