Pharmaceuticals and nutritional products maker Bristol-Myers Squibb Co. (BMY), Monday announced the approval of T-cell Co-Stimulation modulator Orencia by the European Commission on January 20, 2010.
Orencia in combination with methotrexate or MTX is used for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis or pJIA in paediatric patients six years of age and older who have had an insufficient response to other disease-modifying anti-rheumatic drugs, including at least one tumour necrosis factor inhibitor.
Juvenile idiopathic arthritis, an autoimmune disease, is the most common form of arthritis affecting children and an important cause of short-term and long-term disability in children. Studies have reported that JIA may affect between 16-150 in every 100,000 children and the disease usually begins before the age of 16.
The company noted that Orencia is designed to act early in the immune cascade by selectively modulating T-cells to reduce downstream inflammatory responses. In combination with MTX, it fills an unmet need by offering a better treatment option for affected children of six years of age and older.
The approval was based on findings from the double-blind, randomised controlled study which evaluated the efficacy and safety of Orencia in patients six to 17 years of age with moderate to severe active pJIA who had an inadequate response to one or more disease-modifying anti-rheumatic drugs, such as MTX or tumour necrosis factor antagonists.
In the three-phase study, it was found that ACR Paediatric responses throughout the study remained consistent for one year and were higher in biologic naïve patients, compared with previously receiving biologic therapy.
The first phase was an open-label, lead-in period where patients received active treatment with Orencia. In the period, Orencia demonstrated meaningful ACR Pedi response rates, with 65%, 49% and 28% of patients achieving an ACR Paediatric 30, 50 and 70, respectively. In addition, the frequency of adverse events was 70% and infections occurred at a frequency of 36% during the period.
In the second phase, the double-blind period where patients who had demonstrated an ACR Paediatric 30 response were randomised to either Orencia or placebo treatment, the patients on Orencia experienced significantly fewer disease flares versus placebo.
The third phase was the open-label extension period open to those patients experiencing flare or completing the second phase as well as non-responders from the first phase.
The findings are also supported by another study which found an improvement in quality of life where treatment with Orencia allowed children to miss fewer school days and parents to get back to usual activities.
Serious infections, at least possibly related to treatment, were reported in 1.8% of patients with Orencia and in 1.0% of patients who received placebo. In the placebo-controlled clinical trials, the frequency of malignancies with Orencia was 1.4% and with placebo 1.1%.
BMY is currently trading at $24.54, down 0.06 or 0.24%, on a volume of 4.09 million shares on the NYSE.
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