FDA Approves BMS’ Orencia for Preventing Graft vs. Host Disease

The FDA has approved Bristol Myers Squibb’s (BMS) Orencia (abatacept) for preventing acute graft vs. host disease (aGVHD), a potentially fatal condition in which donor bone marrow or stem cells attack the person receiving a transplant.

Orencia is indicated for adults and children two years and up undergoing hematopoietic stem cell transplantation from an unrelated donor, which results in higher instances of aGVHD than if the donor were a family member.

The approval was based on positive data from two clinical studies with a combined total of 402 patients, demonstrating that Orencia improved overall survival.

Orencia first secured FDA approval in 2005 for treating adult rheumatoid arthritis.