DEC 04, 2019: Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.
GvHD after a hematopoietic stem cell transplant occurs when transplanted donor T-cells recognize antigenic differences between donor and recipient and attacks the recipient’s healthy tissue and organs.
Stem cell transplant infusions include donor T-cells, a type of white blood cell that recognizes and destroys foreign invaders in the recipient’s body including cancer cells.
GvHD occurs when the donor T-cells also recognize the patient’s healthy cells as foreign and start attacking healthy tissues and organs.
T-cell activation requires a signaling process called co-stimulation. ORENCIA, a therapy currently approved to treat various arthritic conditions, binds to and inhibits protein targets involved in co-stimulation, thus inhibiting T-cell activation.
ORENCIA® is an immunomodulator that disrupts the continuous cycle of T–cell activation that characterizes Rheumatoid Arthritis. https://news.bms.com/press-release/rd-news/bristol-myers-squibb-announces-us-fda-breakthrough-therapy-designation-orencia