Gilead Sciences' closely-watched hepatitis C drug Sovaldi has been given the green light in Europe.
The European Commission has granted marketing authorisation for Sovaldi (sofosbuvir) 400mg tablets which, as part of HCV combination therapy with peg-interferon and ribavirin, offers cure rates of around 90% in previously-untreated adults. However, most significant is that the once-daily nucleotide analogue polymerase inhibitor is the first all-oral treatment option for up to 24 weeks for patients unsuitable for interferon.
John Martin, Gilead chief executive, said the approval is an important step forward in the management of HCV in Europe, "enabling many more patients the opportunity of cure.” He added that "we are committed to working with local governments and health systems to ensure sofosbuvir is made available" and the company noted that in the UK the drug is already been evaluated by the National Institute for Health and Clinical Excellence and the Scottish Medicines Consortium.
Graham Foster at the Queen Mary University of London noted that unlike many chronic diseases, HCV can be cured but many patients, for a number of reasons, have not currently achieved a cure and often progress to end-stage liver disease or liver cancer. Now, "with high cure rates across a broad range of patients and a short duration of therapy, sofosbuvir is a very welcome therapeutic advance that will increase the number of patients who can be treated and ultimately cured."
Sovaldi was approved in the USA in December.