GSK receives FDA approval for Promacta

GlaxoSmithKline (GSK) announced that the USFDA has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta (eltrombopag) in patients with severe aplastic anaemia (SAA), who have had an insufficient response to immunosuppressive


Dr Paolo Paoletti, president, Oncology, GSK

SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets.

"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 Dr Paolo Paoletti, president, Oncology, GSK.

Dr Paoletti further added, "Through collaboration with the National Institutes of Health, whose studies demonstrate the potential for Promacta to achieve a haematologic response in at least one lineage of red blood cells, platelets, or white blood cells, and patients now have a treatment option where one didn't previously exist."

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