LEIDEN, The Netherlands, June 30, 2016 – Janssen Biologics B.V. (Janssen) announced today that the European Commission (EC) has approved SIMPONI® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA). SIMPONI in combination with methotrexate (MTX) is approved for use in children with a body weight of at least 40 kg and who have responded inadequately to previous treatment with MTX. The EC approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2016 recommending the use of SIMPONI for pJIA, the most common type of arthritis in children under the age of 17 in which the predominant symptoms are persistent joint pain, swelling and stiffness. It is estimated that nearly 60,000 children in Europe are affected by juvenile idiopathic arthritis.1
“The European Commission approval of SIMPONI for the treatment of polyarticular juvenile idiopathic arthritis is an important milestone for patients and pediatric rheumatologists,” said Newman Yeilding, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC. “We are pleased to make SIMPONI available for this debilitating form of inflammatory arthritis for patients and caregivers in Europe.”
Data from the Phase 3 GO KIDS trial, a Janssen-sponsored program conducted in collaboration with MSD (known as Merck in the United States and Canada), served as the basis for EC approval.
About GO KIDS
GO KIDS evaluated the efficacy and safety of SIMPONI in 173 children (2 to 17 years of age) with pJIA and active arthritis in at least five joints that had poor response to MTX. Part 1 of the study consisted of a 16-week open-label phase, in which enrolled patients received SIMPONI 30 mg/m2 (maximum 50 mg) subcutaneously every four weeks and MTX. The 154 patients who achieved an American College of Rheumatology (ACR) Pediatric (Ped) 30 response at week 16 entered Part 2 of the study, the randomised withdrawal phase, and received SIMPONI 30 mg/m2 (maximum 50 mg) and MTX or placebo and MTX every four weeks.
The primary endpoint, the proportion of patients who achieved ACR Ped 30 response at week 16 and who did not experience a flare between week 16 and week 48, did not reach statistical significance; the majority of patients did not experience a flare between week 16 and week 48 (59 percent in the SIMPONI and MTX and 53 percent in the placebo and MTX groups, respectively; P = 0.41). However, pre-specified subgroup analyses of the primary endpoint by baseline CRP (=1 mg/dL vs <1 mg/dL) demonstrated higher flare rates in placebo and MTX compared to SIMPONI and MTX treated patients among patients with baseline CRP =1 mg/dL (87 percent vs 40 percent, P = 0.0068). In this study, the type and frequency of adverse events reported were generally similar to those seen in adult rheumatoid arthritis (RA) studies.
About Polyarticular Juvenile Idiopathic Arthritis
Polyarticular juvenile idiopathic arthritis, also known as juvenile rheumatoid arthritis, is a type of arthritis characterised by persistent joint pain, swelling and stiffness.2 The disease can cause serious health complications, such as growth problems and eye inflammation.3 The European League Against Rheumatism (EULAR) defines seven subcategories of pJIA, with most forms more common in females than males.4 While the cause of pJIA is unknown, heredity and environment are both thought to be factors.3 About SIMPONI® (golimumab) SIMPONI is a human monoclonal antibody that targets and neutralises excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. SIMPONI is approved in more than 85 countries for rheumatologic indications including rheumatoid arthritis (RA), ankylosing spondylitis and psoriatic arthritis. In the European Union (EU), SIMPONI received European Commission approval in October 2009 for the treatment of moderate-to-severe, active RA in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis alone or in combination with methotrexate and for the treatment of severe, active ankylosing spondylitis. In September 2013, SIMPONI received European Commission approval for the treatment of moderately to severely active ulcerative colitis in adults. In June 2015, SIMPONI received European Commission approval for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation. SIMPONI is available either through the SmartJect® autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection.
Janssen Biotech, Inc. discovered and developed SIMPONI and markets the product in the United States. The Janssen Pharmaceutical Companies market SIMPONI in Canada, Central and South America, the Middle East, Africa and Asia Pacific.
In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc.
In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries.
