The supplemental biologics license application (sBLA) is based on data a double-blind, randomized trial that consisted of three periods; the first period involved a four-month open-label lead-in treatment period in which all participants (six to 17 years old) received Orencia and both clinical response and safety were assessed, while the second period involved a six-month randomized double-blind withdrawal phase in which responders received either Orencia or placebo and time to disease flare and safety were assessed.
The final phase involved an open-label phase in which all participants received Orencia in order to assess long-term efficacy and safety.
Bristol-Myers Squibb discovered and developed Orencia, which is approved in the US as a treatment for adults with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.