Revolade™ (eltrombopag) is the first oral, once-a-day platelet generator approved
by Health Canada for patients with ITP
MISSISSAUGA, ON, Jan. 25 /CNW/ - 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.
Revolade™ may also be considered as second-line treatment for adult
non-splenectomised patients, where surgery is contraindicated.1 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. 2 ITP 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
thrombopoietin. 7-8 Megakaryocytes are the bone marrow cells which give rise to blood
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. 10 Healthy 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.11 Quality of life is adversely affected in patients with chronic ITP, with
a fear of bleeding limiting patients' daily activities.4 Fatigue 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.
Product Monograph of RevoladeTM (eltrombopag), GlaxoSmithKline Inc., January 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/assets/pdf/itp_adult_web1.pdf. 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
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.
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