Pharma/Biotech Update: GlaxoSmithKline Seeks Additional Indication
November 12, 2014; Posted by: WeBleed staff
Companies seek new anemia indication for Revolade™.
If you have been diagnosed with severe aplastic anemia (SAA), a drug indication is in the works for treatment. Revolade™ (eltrombopag) was submitted to the European Medicines Agency (EMA) for the treatment indication of severe aplastic anemia and immunosuppressive therapy (IST) according to a release by BusinessWeek today.
In August of this year, eltrombopag, known as Promacta™ in the USA and as Revolade in Europe 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. It is approved in more than 95 countries worldwide for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and in 43 countries worldwide for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
For those who are not familiar with SAA, it is a blood disorder where the bone marrow fails to make enough new blood cells in the body. Currently, there are no approved therapies available in the European Union (EU) for patients with SAA and approximately 40% die from infection or bleeding within five years of their diagnosis.
Promacta™/Revolade™ are both produced by GlaxoSmithKline (GSK).
Photo Credit – GlaxoSmithKline
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