FDA backs added indication for GSK’s Promacta

The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s (LSE: GSK) supplemental New Drug Application (sNDA) for the once-daily use of Promacta (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).

SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets.Eltrombopag, an oral thrombopoietin (TPO) receptor agonist, works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.1

“FDA approval of Promacta addresses a significant treatment need for this very rare but serious blood disorder in those who have failed current treatment options,” said Paolo Paoletti, president of oncology at GSK, adding: “Through collaboration with the National Institutes of Health, whose studies demonstrate the potential for Promacta to achieve a hematologic response in at least one lineage – red blood cells, platelets, or white blood cells – patients now have a treatment option where one didn’t previously exist.”