GSK seeks European approval for additional indication of eltrombopag to treat SAA

Severe aplastic anaemia is a rare disorder in which the bone marrow fails to make enough new blood cells. Currently, there are no approved therapies available for SAA patients in the EU.

Around 40% of those patients unresponsive to initial IST, die from infection or bleeding within five years of their diagnosis.

The EMA submission is based on the results of a pivotal open-label Phase II trial (ELT112523) and two supporting Phase II trials ELT116826 and ELT116643 by the National Institute of Health evaluating eltrombopag in SAA patients.

Eltrombopag is marketed as Promacta in the US and as Revolade in Europe and other countries across the world.

In August 2014, the US Food and Drug Administration (FDA) approved eltrombopag for once-daily use in patients with SAA who have had an insufficient response to IST.

The company said that eltrombopag is not approved or licensed anywhere else in the world for use in SAA.

Additionally, eltrombopag is approved in more than 95 countries worldwide to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

It has also been approved in 43 countries worldwide to treat thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.

Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.