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news.GlaxoSmithKline (GSK) has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for Promacta (eltrombopag) to treat cytopenias (a reduction in blood cells) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
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Severe aplastic anaemia is a rare disorder in which the bone marrow fails to make enough new blood cells.
Currently, there are no approved therapies available for SAA patients unresponsive to IST.
The company said that of those patients unresponsive to initial IST, about 40% die from infection or bleeding within five years of their diagnosis.
In February 2014, the company had secured FDA granted Breakthrough Therapy designation for Promacta in SAA.
The sNDA is based on the results from an open-label, Phase II National Institute of Health (NIH) study of eltrombopag carried out in 43 heavily pre-treated SAA patients with an insufficient response to IST.
Eltrombopag, which is marketed as Promacta in the US and Revolade in Europe and other countries across the world, is not approved or licensed anywhere in the world for use in SAA.