Gilead Sciences’ rapidly growing hepatitis C business has gained another boost with the European approval of its combination treatment Harvoni.
The European Commission (EC) confirmed an earlier recommendation from the European Medicines Agency (EMA) for the use of the drug – a combination of Gilead’s record-breaking Sovaldi and ledipasvir – to treat patients with chronic hepatitis C.
The drug is recommended for people with genotype 1 or 4 variations of hepatitis C regardless of whether they have had prior treatment or have cirrhosis. The recommended treatment duration is 12 or 24 weeks depending on prior treatment history and cirrhosis status.
An eight-week course of Harvoni may be also considered in non-cirrhotic treatment-naïve genotype 1 patients, while a combination of Harvoni and ribavirin may be considered in certain patients with genotypes 1, 3 and 4.
The approval is another major step for Gilead’s Sovaldi franchise, which has been the most lucrative pharma launch of all time, achieving sales of $8.5bn during the first nine months of 2014.
Sovaldi’s success has been primarily due to its more convenient treatment regimen as it allows patients to be treated without the need for weekly injectable interferon.
Harvoni extends this convenience further as the oral treatment eliminates the need for interferon and ribavirin, both of which can be difficult for patients to tolerate.
The combination treatment was approved in the US last month and expectations are high among the hepatitis C community as trials have demonstrated Harvoni can cure as many as 90% of patients within just eight weeks.
Competition has emerged though in the form of a combination of Janssen’s NS3/4A protease inhibitor Olysio (simeprevir) and Sovaldi, which was approved by the US FDA earlier this month and also offers an all-oral, interferon and ribavirin-free option for hepatitis C patients.