GSK announces US regulatory submission seeking additional indication for eltrombopag (Promacta™)
Issued: London, UK
GSK today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for eltrombopag (Promacta™), seeking an additional indication in paediatric patients six years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
Characterised by a low platelet count, ITP affects as many as 5 in 100,000 children each year.1 While many children with acute ITP do not require treatment and/or their disease resolves, up to 30 percent of patients experience persistent disease at 12 months and are diagnosed with chronic ITP.2,3,4 Patients with paediatric chronic ITP are at a risk of severe bleeding.
The sNDA application is based on the results from two studies in paediatric chronic ITP, the phase III PETIT2 study (TRA115450) and the phase II PETIT study (TRA108062).
Eltrombopag, marketed as Promacta in the USA and Revolade™ in the EU and rest of world, is not approved or licensed anywhere in the world for use in chronic ITP in the paediatric setting.
For the full US Prescribing Information for Promacta, including Boxed Warning, visit https://www.gsksource.com/gskprm/htdocs/documents/PROMACTA-PI-MG-COMBINED.PDF. For the full EU Patient Information Leaflet or Summary of Product Characteristics (SPC) for Revolade (eltrombopag) please visit http://health.gsk.com/.
Promactaand Revoladeare trademarks of the GSK group of companies.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit gsk.com.
1. Terrell DR, Beebe LA, Vesely SK, Neas BR, Segal JB, George JN.Am J Hematol. 2010 Mar;85(3):174-80. doi: 10.1002/ajh.21616.
2. El-Bostany E, El-Ghoroury E, and El-Ghafar E. Anti-Beta 2 Glycoprotein I in childhood immune thrombocytopenic purpura. Blood Coagulation and Fibrinolysis. 2008;19(1):26-31.
3. BCSH, (British Committee for Standards in Haematology). Guidelines for the investigation and management of idiopathic thrombocytopenic purpura in adults, children and in pregnancy. Br J Haematol. 2003;120:574-596.
4. Walker R.W., Walker W. Idiopathic thrombocytopenia, initial illness and long term follow up. Archives of Disease in Childhood. 1984;59:316-322.