Bristol Myers Squibb just got some good news on its quest to transform aging arthritis med Orencia into a preventive therapy for transplant rejection.
The FDA has blessed abatacept—approved as Orencia in rheumatoid arthritis since 2005—with a priority review tag for approval to prevent moderate-to-severe acute graft-versus-host disease (aGvHD).
The drug is bound for a Dec. 23 decision date and, if it passes muster with the FDA, would be cleared for patients ages six and up receiving hematopoietic stem cell transplants from unrelated donors.
Stem cell transplants include infusions of donor T cells, which are used to attack cancer cells. In GvHD patients, though, donor T cells can take aim at healthy tissues and organs.
AGvHD crops up in 30% to 70% of transplant patients, based on donor type, transplant technique and other factors. BMS believes Orencia could help stymie transplant rejection by binding to and inhibiting proteins involved in co-stimulation—a signaling process that queues up T cells to attack.
Bristol Myers’ application included data from Orencia’s mid-stage ABA2 study, plus a registry trial based on real-world evidence. Orencia patients in ABA2 saw a “significant reduction” in severe aGvHD and related morbidity, while disease relapse rates remained level, BMS said. The real-world analysis yielded results “consistent” with those from ABA2, the company said.
