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GSK files Promacta for anaemia indication in US

FDA will review drug under ‘breakthrough’ designation
GSK GlaxoSmithKline house

GlaxoSmithKline (GSK) has submitted its US filing for the use of Promacta in a new anaemia indication.

The US FDA will now review the drug for use in the treatment of patients with severe aplastic anaemia (SAA) who have a reduced number of blood cells, a condition known as cytopaenia. This indication covers patients who have had an insufficient response to immunosuppressive therapy to reduce the activity of the immune system.

As reported last month, this review will be expedited due to the FDA's decision to grant 'breakthrough status' to Promacta (eltrombopag). This designation is intended to speed up the review process for significant new medicines for serious diseases and is reserved for drugs that have demonstrated a substantial improvement over current therapies.

Promacta fits into this category due to the severity of SAA, a condition in which the bone marrow fails to make enough new blood cells. There are no therapies currently approved for SAA patients who are unresponsive to immunosuppressive therapy, and about 40 per cent of these patients die from infection or bleeding within five years of diagnosis, according to GSK.

In addition to the accelerated assessment through the breakthrough status, GSK can also expect more intensive guidance from the FDA during the review process.

If given the green light this would be Promacta's third recommendation in the US, following approvals for the treatment of low blood cell counts in adults with one of two conditions: chronic hepatitis C - before and during treatment with interferon, or chronic immune thrombocytopaenia when certain treatments have not worked.

GSK developed the drug with partners Ligand, which receives royalties on Promacta sales. Outside the US, the drug is known as Revolade.

3rd March 2014

From: Sales



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