Subcutaneous Orencia abatacept regulatory update

Bristol-Myers submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for subcutaneous Orencia abatacept to treat rheumatoid arthritis in patients with an inadequate response to conventional therapy. An IV formulation of abatacept, a CTLA-4-Ig fusion protein, is already marketed in Japan for the indication. Ono has co-development and co-commercialization rights to the product under an expanded 2009 deal (see BioCentury, Sept. 26, 2011). ...