According to a report by Pharmalive, the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended the approval (13 votes to 5) of belatacept for the prophylaxis of acute rejection in de novo renal transplant patients.

The recommendation is based on a review of data from two phase III studies and one phase II study which included more than 1,000 patients who received belatacept.