On February 3rd, GlaxoSmithKline (GSK) announces that Promacta (US)/Revolade (Europe) (Eltrombopag) receives the coveted FDA Breakthrough Therapy Designation (BTD) for cytopenias in patients with Severe Aplastic Anemia (SAA), who have had insufficient response to Immunosuppressive Therapy (IST). The drug is not approved or licensed anywhere in the world for this indication.
SAA is a rare disorder where the bone marrow fails to make enough new blood cells.