News Release - January 25, 2011
New therapy option approved in Canada for chronic immune thrombocytopenic purpura (ITP) Revolade™ (eltrombopag) is the first oral, once-a-day platelet generator approved by Health Canada for patients with ITP
Revolade™ (eltrombopag) is the first oral, once-a-day platelet generator approved by Health Canada for patients with ITP
Mississauga, ON (January 25, 2011) - GlaxoSmithKline Inc. (GSK) announced today that Health Canada has approved Revolade™ (eltrombopag), for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Revolade™ is indicated for adult chronic ITP patients who have had their spleens removed (splenectomised) and have not responded (are refractory) to first-line treatments, such as corticosteroids and immunoglobulins. 1Revolade™ may also be considered as second-line treatment for adult non-splenectomised patients, where surgery is contraindicated. Revolade™ therapy should not exceed one year of continuous treatment. After one year of continuous treatment, therapeutic options should be reassessed.
"Eltrombopag (Revolade™) as a once-a-day oral medication, represents an innovative step forward in helping patients and their physicians meet the challenges of managing refractory chronic ITP", said Dr Harold J. Olney, Chief, Department of hematology and transfusional medicine, University of Montréal Hospital Centre, "Clinical trials that we have been a part of have shown that Revolade™ is able to stimulate the production of platelets and helps to reduce the risk of bleeding, in this difficult-to-treat area of the disease."
According to the Canadian Agency for Drugs and Technologies in Health there are approximately 6,090 chronic adult ITP cases in Canada. 2ITP patients experience bruising and bleeding and, in some cases, serious haemorrhages, which can be fatal. ITP may also affect a patient's quality of life, as it is often associated with fatigue and depression3, and a fear of bleeding may limit everyday activities.4
The approval is based on the results from two Phase III, randomized, double-blind, placebo-controlled clinical trials (TRA100773B5 and RAISE TRA1025376), in adults with previously treated ITP.
Revolade™: the first approved, oral, platelet generator
Revolade™ is an oral thrombopoietin receptor agonist. It works by stimulating platelet production from megakaryocytes in a similar way to native thrombopoietin7-8. Megakaryocytes are the bone marrow cells which give rise to blood platelets.9
Revolade™ was discovered as a result of a research collaboration between GSK and Ligand Pharmaceuticals (NASDAQ: LGND), and developed by GSK. Revolade™ is authorized for use in the United States under the trade name Promacta™. It is also approved under the trade name Revolade™ in the European Union, Bahrain, Kuwait, Chile and Russia.
About chronic ITP
Chronic ITP is a serious condition, where patients have low platelet levels (defined as <100 x 109/L) in the blood. 10Healthy individuals usually have platelet counts of 150- 400 x 109/L. Platelets are essential to normal clotting, so patients with ITP are at increased risk of bleeding, and may develop bruises and experience nose or gum bleeds, have blood in the urine or faeces, abnormally heavy menstrual bleeding, or other types of bleeding that are difficult to stop. Although very rare in occurrence, bleeding in the brain or gastrointestinal tract may also occur, and is potentially fatal. 11Quality of life is adversely affected in patients with chronic ITP, with a fear of bleeding limiting patients' daily activities. 4Fatigue and depression are also often associated with the disease.3
About GlaxoSmithKline Inc.
GlaxoSmithKline Inc. (GSK) is a leading research-based pharmaceutical company with a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better, and live longer. This mission gives GSK the purpose to develop innovative medicines, vaccines and healthcare solutions that help millions of people. GSK is consistently recognized as one of the 50 best employers in Canada and is a top 15 investor in Canadian research and development, contributing more than $144 million in 2009 alone. With a proud tradition of charitable and community support, GSK is designated a Caring Company by Imagine Canada. Discover more at GSK.ca.
™REVOLADE and ™PROMACTA used under license by GlaxoSmithKline Inc.
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- Product Monograph of RevoladeTM (eltrombopag), GlaxoSmithKline Inc., Jan 2011
- Canadian Agency for Drugs and Technologies in Health: http://www.cadth.ca/media/pdf/298A_Polyclonal-Intravenous-Immunoglobulin_tr_e.pdf Accessed January 2011.
- Platelet Disorder Support Association (PDSA): About ITP. http://www.pdsa.org/about-itp.html. Accessed January 2011.
- Mathias SD, Gao SK, Miller KL, et al. Impact of chronic immune thrombocytopenic purpura (ITP) on health-related quality of life: a conceptual model starting with the patient perspective. Health Qual Life Outcomes 2008; 6:13.
- Bussel JB, Provan D, Shamsi T, et al. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet 2009; 373:641-8.
- Cheng G, Saleh M, Bussel J, et al. Oral eltrombopag for the long-term treatment of patients with chronic idiopathic thrombocytopenic purpura: results of a Phase III, double-blind, placebo-controlled study (RAISE). Blood 2008;112:400. [ASH Annual Meeting Abstracts].
- Psaila B, Bussel J, Vasey S, et al. Efficacy and safety of repeated intermittent treatment with eltrombopag in patients with chronic ITP. Abstract 0294 presented at the 13th congress of the European Haematology Association, June 2008.
- Saleh M, Bussel JB, Cheng G, et al. Eltrombopag is efficacious in patients with refractory chronic idiopathic thrombocytopenic purpura (ITP) - data from the EXTEND Study. Blood 2008; 112:401 [ASH Annual Meeting Abstracts].
- Erickson-Miller CL, Delorme E, Tian SS, et al. Preclinical activity of eltrombopag (SB-497115), an oral, nonpeptide thrombopoietin receptor agonist. Stem Cells 2009; 27:424-30.
- Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 009;113(11):2386-2393.
- Yilmaz S, Demircioglu F, Turker M et al. An extremely uncommon complication of ITP: spontaneous rupture of an ovarian follicle cyst and massive intra-abdominal bleeding. J Pediatr Hematol Oncol. 2006;28:755-6.