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news.GlaxoSmithKline (GSK) has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) seeking approval for additional indication of eltrombopag (Promacta) to treat paediatric patients six years and older with chronic immune (idiopathic) thrombocytopenia (ITP).
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The drug will be indicated for ITP patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
ITP is characterized by a low platelet count and it affects as many as five in 100,000 children each year.
Many children with acute ITP do not require treatment and/or their disease resolves and about 30% experience persistent disease at 12 months and are diagnosed with chronic ITP.
The sNDA is based on the results from two trials in paediatric chronic ITP, the Phase III PETIT2 trial (TRA115450) and the Phase II PETIT trial (TRA108062).
Marketed as Promacta in the US and Revolade in the EU and rest of world, eltrombopag is not approved or licensed anywhere in the world for use in chronic ITP in the paediatric setting.
Earlier in August, the FDA has approved the company’s sNDA for Promacta (eltrombopag) to treat patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
The approval was based on results from an investigator-sponsored Phase II trial (09-H-0154) carried out by the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH).
Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.