By RTT News, August 26, 2014, 06:00:00 PM EDT

(RTTNews.com) - GlaxoSmithKline plc (GSK, GSK.L) said Tuesday the U.S. Food and Drug Administration approved a supplemental New Drug Application for the once-daily use of Promacta (eltrombopag) in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.

Severe aplastic anaemia, or 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, GSK.

Promacta gained Breakthrough Therapy designation status from the FDA in January 2014 and Priority Review in April 2014. Today's approval by the FDA is based on results from an investigator-sponsored Phase II study conducted by the National Heart, Lung and Blood Institute at the National Institutes of Health.

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GSK: FDA OKs Promacta SNDA In Patients With Aplastic Anaemia