BMS’ Orencia (abatacept) Receive the FDA’s Breakthrough Therapy Designation to Prevent Acute Graft-Versus-Host Disease After Stem Cell Transplant

Shots:

• The US FDA BT’s designation is based on P-II study assessing the impact of Orencia on the prevention of severe acute GvHD when added to a standard GvHD prophylactic regimen in patients with hematologic malignancies receiving a stem cell transplant from an unrelated, HLA-matched or mismatched donor
• A BT designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition
• Orencia is an immunomodulator targeting proteins involved in co-stimulation, thus inhibiting T-cell activation and is an approved therapy to treat multiple RA conditions. If approved by FDA, Orencia will be the first approved therapy to prevent acute GvHD

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