The FDA approved an expanded indication for GlaxoSmithKline’s Promacta (eltrombopag) to include severe aplastic anemia. The drug was previously indicated for chronic immune thrombocytopenia.
The aplastic anemia indication is for patients who have not responded to immunosuppressive therapy. The condition is the underproduction of red blood cells, white blood cells and platelets, and GSK’s oral medication is intended to stimulate the bone marrow to produce new blood cells.
The rare disease is often acquired, but there are a few cases in which it is inherited. Treatments can include blood transfusions, stem cell transplants and stimulants, like GSK’s Promacta. The Mayo Clinic also indicates that stimulants such as Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim) can also be used to stimulate the bone marrow to produce new blood cells. Amgen’s drugs are indicated for chemotherapy treatments.
The FDA granted GSK’s just-approved indication Breakthrough Therapy designation in January and Priority Review status in April.
