FDA Gives Priority Review to BMS’ Orencia for Preventing Acute Graft Vs. Host Disease
Bristol Myers Squibb’s supplemental biologics license application (sBLA) for its approved arthritis drug Orencia (abatacept) has earned a Priority Review by the FDA for preventing moderate-to-severe acute graft vs. host disease (aGvHD) in patients six years and older.
The agency will review the immune system modulator for patients receiving blood stem-cell transplants from unrelated donors. If approved, it would become the first approved treatment for preventing aGvHD.
Orencia was previously approved for treatment of adult rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and adult psoriatic arthritis. The FDA’s target decision date for the supplemental application is Dec. 23.