EMA Advisory Committee Recommends New Use for BMS’ OrenciaBy
Bristol-Myers Squibb (BMS) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending the approval of Orencia (abatacept) intravenous (IV) infusion and subcutaneous injection in combination with methotrexate (MTX), for treating highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. The recommendation will next be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
Orencia is currently approved in the US for moderate-to-severe RA in adults and moderate-to-severe active polyarticular juvenile iodpathic arthritis in pediatric patients six years of age and older. The drug had 2015 global sales of nearly $1.9 billion.