FDA Accepts Bristol-Myers Squibb’s BLA For Belatacept

Bristol-Myers Squibb has announced that FDA has accepted its submission of a biologic license application for belatacept, for filing and review. Belatacept is in ongoing phase III development for use in kidney transplantation.

Elliott Sigal, executive vice president, chief scientific officer and president, R&D at Bristol-Myers Squibb, said: “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.”

Belatacept, an investigational agent under development, is intended to help prevent graft rejection and maintain kidney function following renal transplantation. Belatacept is being studied to assess its efficacy and safety as a maintenance immunosuppressant agent, said the company.