British drug-maker GlaxoSmithKline (GSK) has submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking an additional indication for eltrombopag (Revolade).
The application was filed for additional indication of the drug to treat adult patients with severe aplastic anaemia (SAA) who 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 no approved therapies available in the European Union (EU) for patients with SAA.
The EMA submission was 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, assessing eltrombopag in patients with SAA.
Eltrombopag is marketed as Promacta in the US and as Revolade in Europe, and other countries worldwide.
In August, eltrombopag received US Food and Drug Administration (FDA) approval for once-daily use in patients with SAA who had an insufficient response to IST.
According to the company, eltrombopag is not approved or licensed for use in SAA, anywhere else in the world.
Eltrombopag was approved in 95 countries to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
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It received approval in 43 countries to treat thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
