FDA approves a novel anti-rejection medication for kidney transplant recipients.

The US Food and Drug Administration (FDA) approved Belatacept (Nulojix, Bristol-Myers Squibb Company) on June 15th, 2011, for the prevention of acute rejection in adult patients who have had a kidney transplant.

This novel biologic agent is a fusion protein composed of the Fc fragment of a human IgG1 immunoglobulin linked to the extracellular domain of CTLA-4. It is an antagonist of the B7 ligands, B7-1 (CD80) and B7-2 (CD86), present on antigen-presenting cells. The CD80 and CD86 are essential precursors to the initiation of "signal 2" in the three-signal transplant model of T-cell activation, This antagonistic effect results in the inability to produce effector cytokines, such as interleukin (IL)-2, and results in inhibition of T-cell activation.It is given in 30-minute intravenous infusions.

Belatacept is approved for use with corticosteroids and the immunosuppressant agents basiliximab and mycophenolate mofetil.

For more information visit: http://www.nulojix.com/hcp/index.aspx