GlaxoSmithKline files for added Revolade indication in EU

UK pharma major GlaxoSmithKline (LSE: GSK) has filed an application with the European Medicines Agency for a variation to the marketing authorization for Revolade (eltrombopag), seeking an additional indication for the treatment of adult patients with severe aplastic anemia (SAA) who have 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 currently no approved therapies available in the European Union for patients with SAA. Of those patients unresponsive to initial IST, around 40% 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 study (ELT112523) and two supporting Phase II studies (ELT116826 and ELT116643) by the National Institute of Health evaluating eltrombopag in patients with SAA.

The drug, which is partnered with USA-based Ligand Pharmaceuticals (Nasdaq: LGND), in 2013 generated sales of £186 million ($295 million), up 46% year-on-year, and £62 million, up 37%, in the third quarter of 2014.