BRIEF—Japan grants label extension to Orencia

Bristol-Myers Squibb and Ono Pharmaceutical have received approval from the Japanese medicines regulator to market Orencia (abatacept) in a new indication.

The Ministry of Health, Labour and Welfare (MHLW) gave the green light to the selective T-cell costimulation modulator as a treatment for active polyarticular juvenile idiopathic arthritis (JIA).

JIA, which affects 10-15 per 100,000 children in Japan, is defined as arthritis of unknown origin that begins under the age of 16 and persists for more than six weeks.

Current treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and biologic products, but these are not always effective and can produce side effects.