The US Food and Drug Administration (FDA) has accepted Bristol-Myers Squibb‘s submission of a biologic license application for belatacept, an investigational agent for use in kidney transplantation.
Belatacept is currently undergoing Phase III trials to assess its efficacy and safety as a maintenance immunosuppressant agent to help prevent graft rejection and maintain kidney function following renal transplantation.
Bristol-Myers Squibb research and development executive vice-president, chief scientific officer and president Elliott Sigal said that Belatacept has the potential to address significant unmet medical needs of transplant patients.
“We are pleased the FDA has accepted our submission and we look forward to continuing to work with the agency,” Sigal said.
Belatacept is a fusion protein designed to be a selective co-stimulation blocker that binds to a specific site on certain cells of the immune system to block the second signal necessary to activate naïve T-cells, which coordinate immune-mediated rejection of transplanted organs.