GlaxoSmithKline files for new EU approval of Revolade

GlaxoSmithKline has applied for a new European regulatory approval of its drug Revolade that would allow it to be used in a new indication.

The company has filed a submission to the European Medicines Agency for a variation to its existing marketing authorisation, allowing Revolade to be prescribed to adult patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.

A rare disorder in which the bone marrow fails to make enough new blood cells, severe aplastic anaemia currently has no approved therapies available in Europe. Approximately 40 percent of those who do not benefit from immunosuppression die from infection or bleeding within five years of diagnosis.

This new submission is supported by the encouraging results of a pivotal open-label phase II study and two supporting phase II studies by the National Institute of Health evaluating the drug in patients with this disease.

Revolade was approved for this indication by the US Food and Drug Administration in August 2014. It is sold under the alternative brand name Promacta in the US.

This comes after the firm filed for regulatory approval of its new anti-IL5 monoclonal antibody therapy mepolizumab, a treatment for severe eosinophilic asthma, in the EU and US earlier this month.