BMS drug gets first US approval to prevent acute GvHD

The FDA said Wednesday that it has approved Bristol Myers Squibb's Orencia (abatacept) for the prevention of acute graft-versus-host disease (GvHD), making it the first drug cleared for this use in the US. The agency said the co-stimulatory inhibitor, which is already approved to treat several arthritic conditions, can be prescribed for patients as young as two years old undergoing haematopoietic stem cell transplantation from an unrelated donor. The filing is supported by data from the Phase II ABA2 trial, also known as GVHD-1, as well as real-world evidence from the GVHD-2 study, evaluating Orencia plus immunosuppressant therapy in patients ?6 years old. GVHD-1 involved 186 patients who underwent stem cell transplantation from a matched unrelated donor. The FDA said that while severe acute GvHD-survival was not significantly improved in patients who received Orencia compared to placebo, the overall survival (OS) rate among those who received the drug was 97%, versus 84% for placebo. For moderate-severe acute GvHD-free survival, the rates for Orencia and placebo were 50% and 32%, respectively. Meanwhile, GVHD-2 used real-world data from patients who underwent stem cell transplantation involving a mismatched unrelated donor. This study looked at outcomes of 54 patients who took Orencia on top of standard immunosuppressive drugs to prevent acute GvHD, and compared them to 162 patients treated with standard immunosuppression alone. The six-month OS rate was 98% for the Orencia arm, versus 75% for the comparator group. Discover our new scientific area weekly newsletters Stay on top of critical developments in top fields of interest. Learn more. Sponsored by FirstWord Pharma The most common side effects of Orencia to prevent acute GvHD include anaemia, hypertension, cytomegalovirus (CMV) reactivation/infection, fever, pneumonia, decreased CD4 lymphocytes, increased levels of magnesium in the blood and acute kidney injury. The FDA noted that patients prescribed Orencia for this indication should be monitored for reactivation of CMV and Epstein-Barr virus. The drug, which brought in sales of $870 million for Bristol Myers Squibb during its most recent completed quarter, was originally approved by the FDA in 2005 to treat rheumatoid arthritis in adults. It has since also been cleared as a treatment for polyarticular juvenile idiopathic arthritis and adult psoriatic arthritis.

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