Novartis AG said the U.S. Food and Drug Administration accepted the supplemental new drug application for the company's anemia drug, Promacta, and granted it priority review status.
The Swiss drugmaker is seeking U.S. approval for Promacta, or eltrombopag, combined with standard immunosuppressive therapy as a first-line treatment for severe aplastic anemia.
Severe aplastic anemia is a rare, life-threatening, acquired blood disorder in which a patient's bone marrow fails to produce enough red blood cells, white blood cells and platelets. As a result, people living with the disease may experience symptoms such as fatigue, trouble breathing, recurring infections and abnormal bruising or bleeding.
The priority review status was based on a study that showed more than 52% of severe aplastic anemia patients who have not undergone treatment previously achieved complete response at six months when treated with the Promacta combination therapy — an increase of 35% compared to those treated with the standard immunosuppressive therapy alone. The overall response rate was 85% at six months.
Promacta, which is marketed as Revolade in most countries outside the U.S., is already approved for severe aplastic anemia in patients who have had an insufficient response to standard immunosuppressive therapy. The drug is also approved for adults and children with chronic immune thrombocytopenia, or low blood platelet count, who do not respond to other treatments and for treating thrombocytopenia in patients with chronic hepatitis C virus infection.
