GlaxoSmithKline (GSK) has submitted a supplemental new drug application (sNDA) to US Food and Drug Administration (FDA) for eltrombopag (Promacta).
GSK are seeking additional approval to treat paediatric patients over the age of six with chronic immune (idiopathic) thrombocytopenia (ITP).
The drug is being indicated for ITP patients who had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
The sNDA application was based on results from two trials in paediatric chronic ITP, the Phase III PETIT2 study (TRA115450) and Phase II PETIT study (TRA108062).
Marketed as Promacta in the US and Revolade in the EU and the rest of the world, eltrombopag has not yet received approval or licensed anywhere worldwide for use for chronic ITP in a paediatric setting.
ITP is characterised by a low platelet count and it affects five in 100,000 children every year.
Most children with acute ITP do not require treatment or their disease clears without treatment. Approximately 30% of patients experience persistent disease at 12 months and are diagnosed with chronic ITP.
In August, the company’s sNDA was approved for Promacta (eltrombopag) to treat patients with severe aplastic anaemia (SAA) whohad an insufficient response to immunosuppressive therapy (IST).
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 at Philadelphia. Photo: courtesy of Beyond My Ken.