GSK announces EU regulatory submission seeking additional indication for eltrombopag (Revolade™)
GSK today announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag (Revolade™), seeking an additional indication for the treatment of paediatric patients (age 1 year and above) with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids or immunoglobulins.
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 EMA submission, based on the results from the phase III PETIT2 study (TRA115450) and the phase II PETIT study (TRA108062) in paediatric chronic ITP, includes the registration of a new 25 mg Powder for Oral Suspension formulation for eltrombopag, as well as a new 12.5 mg tablet.
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/.
Promacta and Revolade are trademarks of the GSK group of companies
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.
- 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.
- 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.
- 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.
- Walker R.W., Walker W. Idiopathic thrombocytopenia, initial illness and long term follow up. Archives of Disease in Childhood. 1984;59:316-322.