New Reblozyl Indication
Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) injection received a third indication from the U.S. Food and Drug Administration (FDA) on Aug. 28, 2023. The first-in-class erythroid maturation agent (EMA) now is approved as initial therapy to treat anemia for adults who have myelodysplastic syndromes (MDS) that are not high-risk, that may need red blood cell (RBC) transfusions to manage and that have not been treated previously with an erythropoiesis-stimulating agent (ESA), such as Epogen® (epoetin alfa). It already was FDA approved to treat anemia for adults who need regular RBC transfusions to treat beta-thalassemia and for adults who have specific types of MDS that have not responded to ESA therapy, resulting in the need for two or more RBC transfusions within a two-month period. Doses are administered subcutaneously (SC) once every three weeks beginning at 1mg/kg and increasing at six-week intervals to no more than 1.75mg/kg for patients who do not respond adequately to lower doses. Unlike ESAs, which prompt immature blood cells to divide early in RBC production; Reblozyl works late in the process to increase RBC availability. However, it should not be used to replace RBC transfusions for patients who have anemia that requires immediate treatment. In the decisive clinical trial for the new indication, 58.5% of patients treated with Reblozyl not only did not need transfusions for at least three months, but they also achieved target hemoglobin levels within six months as opposed to 31.2% of patients who reached both goals after being given epoetin alfa. Some patients using Reblozyl may experience blood clots, high blood pressure, or extramedullary hematopoietic (EMH) masses (blood cell formation outside of the bone marrow). Check here for complete prescribing information.
FDA Approves Ilaris to Treat Gout Ilaris® (canakinumab – Novartis) injection was granted an FDA indication for gout on Aug. 25, 2023. It now is FDA approved for the treatment of gout flares for adults who cannot use non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine and who are not candidates for multiple treatments with corticosteroids. Since its first FDA approval for cryopyrin-associated periodic syndrome (CAPS) in 2009, Ilaris has received additional indications for other types of periodic fevers and for Still’s disease, a variant of systemic juvenile idiopathic arthritis (SJIA). A monoclonal antibody that inhibits interleukin-1 beta (IL-1β), it is injected SC to decrease inflammation. Ilaris’ recommended dosing for a gout flare is one 150mg injection, which should not be repeated for at least four months. A Medication Guide supplied by Ilaris warns that patients using it have a higher-than-normal risk of developing serious infections. Other adverse effects may include back pain and increased triglyceride levels. Here is the prescribing information.