UK drug giant GlaxoSmithKline received some good news this week as its blood disorder drug Revolade moved a step closer to gaining marketing approval in the Europe Union.

Advisors to the European Medicines Agency have issued a positive opinion for the approval of Revolade (eltrombopag) as an oral treatment for thrombocytopenia in adults with chronic immune thrombocytopenic purpura (ITP), pushing the drug a step closer to full approval in the region.

Specifically, the Committee for Medicinal Products for Human Use has recommended that Revolade be given the green light for the treatment of ITP in adult patients who have had their spleen removed and do not respond to other therapies, such as corticosteroids and immunoglobulins, and as a second-line therapy for patients in whom spleen removal is inappropriate.

The decision came on the back of findings from a comprehensive clinical trial programme in which Revolade clearly demonstrated its potential benefits to patients with the disease, including: significant increases in platelet counts; a reduction in the incidence of bleeding; and an improvement in quality of life, compared with placebo (plus the standard of care). In addition, the drug was shown to be well-tolerated in patients and also lead to a dose reduction in concomitant medications, such as steroids, the firm said.

“Eltrombopag is an innovative treatment for thrombocytopenia in patients with chronic ITP…able to stimulate platelet production and reduce the risk of bleeding in a difficult-to-treat disease,” noted Paolo Paoletti, senior vice president and global head of oncology research and development at GSK.