Promacta Receives Expanded Approval
November 16, 2018 – The U.S. FDA has approved an expanded indication for Promacta® (eltrombopag), manufactured by Novartis. The drug is now indicated to provide first-line treatment, in combination with standard immunosuppressive therapy (IST), for adults and pediatric patients at least two years of age who have severe aplastic anemia (SAA).
SAA is a rare but life-threatening condition. It occurs when the body’s bone marrow fails to produce enough blood cells. The condition has a number of different causes, including autoimmune disorders, pregnancy, viral infections, exposure to certain chemicals or drugs, and treatment with chemotherapy or radiation.
In a clinical study, 44% of patients treated with Promacta and IST achieved a complete response after six months. The rate is 27% higher than that observed historically with IST alone. The overall response rate was 79%. Recommended dosing depends on the indication. A black box warning indicates that Promacta may increase the risk of hepatic decompensation when used with interferon and ribavirin in patients who have chronic hepatitis C. The black box warning also cautions that Promacta may increase the risk of severe and potentially life-threatening hepatotoxicity. Patient liver function should be monitored, and Promacta dosing adjusted as appropriate.
Promacta first received FDA approval in 2008. In addition to the expanded approval, it is indicated to treat: SAA in patients who have had an insufficient response to IST; chronic immune thrombocytopenia (ITP) in adults and children who are refractory to other treatments; and thrombocytopenia in patients with chronic hepatitis C virus (HCV) infection.