DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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25 July 2013
The National Institute for Health and Care Excellence (NICE) in the UK has recommended immune disorder drug Revolade for use on the NHS after a process of three and a half years.
The GSK once-daily oral treatment is now available to adult patients in England and Wales living with chronic immune (idiopathic) thrombocytopenic purpura (cITP), an immune disorder associated with low-blood platelet counts.
In patients with cITP, the immune system prematurely destroys platelets or impairs their production so that platelets are lost from the circulation faster than they can be replaced from the bone marrow, where they are made.
This results in patients developing mild bruising or serious bleeding, which affects their quality of life and, in some instances, may be fatal.
It is estimated that cITP currently affects 50 in 100,000 people in the UK.
The only other licensed TPO-RA recommended by NICE is romiplostim, which is given in the form of a weekly injection.
The Royal London Hospital’s clinical director for pathology Prof Adrian Newland said: “I was very pleased to see that NICE has recognised the clinical value and cost-effectiveness of eltrombopag in their guidance.
“We now have an important addition to the treatment options for patients with severe or refractory disease.”
Revolade is an oral thrombopoietin receptor agonist (TPO-RA) that stimulates the growth and maturation of cells in the bone marrow (megakaryocytes) that produce platelets, increasing platelet production.
When added to conventional immunosuppressive therapy, Revolade, also known as eltrombopag, increases response rates compared with placebo and in some patients.
GlaxoSmithKline UK general manager Erik Van Snippenberg said: “This has been a lengthy three and a half year long appraisal process. We are pleased that NICE has recommended eltrombopag and that the small number of cITP patients in England and Wales are granted access to an alternative treatment option offering the benefit of oral convenience.
“With eltrombopag, we hope to ultimately make a meaningful difference in the quality of life of cITP patients and contribute to potential savings for the NHS.”
New Drug Approvals 