GlaxoSmithKline’s (GSK) hepatitis C drug Revolade (eltrombopag) has been given marketing authorisation for an additional indication by the European Commission.
The new indication for Revolade is as a treatment for low platelet counts (thrombocytopenia) in adults with chronic hepatitis C infection.
Thrombocytopenia can occur in people with chronic hepatitis C infection due to liver damage, and is a common side effect of peginterferon (pIFN) based therapy.
Marketing authorisation given to eltrombopag is based on results from two ‘Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE’ (ENABLE) Phase III clinical trials, which consisted of an open-label pre-antiviral treatment phase and a randomised, double-blind, placebo-controlled antiviral treatment phase.
The Phase III trials demonstrated that eltrombopag could reach and sustain target platelet counts in chronic hepatitis C patients with associated thrombocytopenia.
GSK oncology president Paolo Paoletti said: "Until now, prescribers were without an option for treating low platelet counts in patients with chronic hepatitis C infection.
"Today’s announcement is important as it means that healthcare professionals can now use Revolade to help patients start and stay on interferon therapy, which will facilitate achieving the best outcome for these individuals that being a sustained virologic response."
GSK markets eltrombopag as Revolade in Europe and most countries outside the US, and as Promacta in the US, as a treatment for thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Treatment will be prescribed to adult patients as a once-daily oral drug, which received approval by the European Commission in September 2013 for chronic hepatitis C-associated thrombocytopenia.
Promacta/Revolade has also been approved for chronic hepatitis C-associated thrombocytopenia in Argentina, Australia, Bangladesh, Pakistan, Philippines and the US.
Image: The GlaxoSmithKline Biologicals facility in Dresden, Germany. Photo: courtesy of Wikipedia.