GSK announces EU regulatory submission seeking additional indication for eltrombopag (Revolade™)
12 November 2014
Issued: London, UK
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 adult patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
SAA is a rare disorder in which the bone marrow fails to make enough new blood cells. There are currently no approved therapies available in the European Union (EU) for patients with SAA. Of those patients unresponsive to initial IST, approximately 40% die from infection or bleeding within five years of their diagnosis.1
The EMA submission is based on the results of a pivotal open-label phase II study (ELT112523) and two supporting phase II studies (ELT116826 and ELT116643) by the National Institute of Health evaluating eltrombopag in patients with SAA.
On 26 August, 2014, eltrombopag—marketed as Promacta™ in the USA and as Revolade in Europe and other countries across the world—was approved by the US Food and Drug Administration for once-daily use in patients with SAA who have had an insufficient response to IST. Eltrombopag is not approved or licensed anywhere else in the world for use in SAA.
In addition, eltrombopag is approved in more than 95 countries worldwide for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and in 43 countries worldwide for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
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 please visit http://health.gsk.com/.
Promacta and Revolade are registered 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 www.gsk.com.
UK Media enquiries:
David Mawdsley +44 (0) 20 8047 5502 (London)
Simon Steel +44 (0) 20 8047 5502 (London)
David Daley +44 (0) 20 8047 5502 (London)
Catherine Hartley +44 (0) 20 8047 5502 (London)
Sarah Spencer +44 (0) 20 8047 5502 (London)
US Media enquiries:
Melinda Stubbee +1 919 483 2510 (North Carolina)
Robin Gaitens +1 919 483 2678 (North Carolina)
Mary Anne Rhyne +1 919 483 0492 (North Carolina)
Sarah Alspach +1 202 715 1048 (Washington, DC)
Jennifer Armstrong +1 215 751 5664 (Philadelphia)
Ziba Shamsi +44 (0) 20 8047 3289 (London)
Kirsty Collins (SRI & CG) +44 (0) 20 8047 5534 (London)
Tom Curry + 1 215 751 5419 (Philadelphia)
Gary Davies +44 (0) 20 8047 5503 (London)
James Dodwell +44 (0) 20 8047 2406 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
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.
1Valdez JM, et al. Decreased Infection-Related Mortality and Improved Survival in Severe Aplastic Anemia in the Past Two Decades. Clinical Infectious Diseases 2011;52(6):726–735