Posted by Michael Wonder on 23 Aug 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Orencia (abatacept) for the prevention of acute graft versus host disease
23 August 2021 - The sBLA is supported by the Phase 2 ABA2 trial evaluating Orencia in adults and children to prevent acute graft versus host disease.
Bristol Myers Squibb today announced that the U.S. FDA has accepted its supplemental biologics license application for Orencia (abatacept) for the prevention of moderate to severe acute graft versus host disease in patients 6 years of age and older receiving unrelated donor haematopoietic stem cell transplantation.
The FDA granted the application priority review and assigned a Prescription Drug User Fee Act goal date of 23 December 2021.
