Juvenile indication for Orencia
Executive Summary
FDA approves Bristol-Myers Squibb's rheumatoid arthritis drug Orencia (abatacep) for moderately to severely active polyarticular juvenile iodiopathic arthritis in pediatric patients six years and older, April 8. The same day, Bristol and Repligen reach an out-of-court settlement regarding royalties due on U.S. sales of the drug. The settlement includes $5 million in past royalties to Repligen and the University of Michigan, the original owner of the patent covering anti-CTLA-4 antibodies. Orencia enters a market that includes Abbott's tumor necrosis factor inhibitor Humira (adalimumab), which was approved in February