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HomeLatest Pharma-NewsU.S. FDA approved BMS Breakthrough Therapy Designation for ORENCIA® (abatacept) just to...

U.S. FDA approved BMS Breakthrough Therapy Designation for ORENCIA® (abatacept) just to help in Preventing Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant

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.

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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 Tcell activation that characterizes Rheumatoid Arthritis.


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