FDA Approves Bristol Myers' Orencia As First Drug To Prevent Graft-Versus-Host Disease

The FDA approved Bristol Myers Squibb & Co's BMY Orencia (abatacept) for the prevention of acute graft-versus-host disease (GVHD) in combination with certain immunosuppressants.

• Orencia combined with calcineurin inhibitor (CNI) and methotrexate (MTX) becomes the first drug approved as a preventative for GVHD.
• The approval comes for adults and pediatric patients two years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.
• The latest approval was based on the Phase 2 ABA2 trial that showed the addition of Orencia to standard prophylaxis (a calcineurin inhibitor plus methotrexate) led to significantly higher acute GVHD-free survival at 180 days after transplant for those in the mismatched unrelated donor arm.
• In the matched unrelated arm, Orencia provided numerically higher acute GVHD-free survival.
• Orencia is also approved to treat adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, and moderate to severe polyarticular juvenile idiopathic arthritis in children 2 and older.
• Related content: Benzinga's Full FDA Calendar.
• Price Action: BMY shares closed at $60.61 on Wednesday.