Gilead Sciences has been granted approval by the European Commission (EC) for Sovaldi, getting a green light for the first all-oral treatment for chronic hepatitis C virus in the EU.
The European regulator approved Sovaldi (sofosbuvir) for use both in combination with pegylated interferon alpha and ribavirin in patients with hepatitis C genotypes 1, 4, 5 or 6, and as an interferon-free regimen alongside ribavirin alone in patients with hepatitis C genotypes 2 or 3 or those awaiting a liver transplant.
Gilead’s drug – which is the first compound in the NS5B polymerase inhibitor class to be registered – was approved for the same indication in the US in December 2013, and analysts are already predicting that it could reach blockbuster sales levels of $1bn or more by the end of this year and $5bn or more at peak.
One reason for the anticipated rapid take-up of Sovaldi is that hepatitis C patients have been delaying treatment – a phenomenon known as ‘warehousing’ – in anticipation of the availability of more effective and tolerable new therapies.
Commenting on the EU approval of Gilead’s drug, hepatologist Graham Foster of Queen Mary University in London, UK, said: “With high cure rates across a broad range of patients and a short duration of therapy, Sovaldi is a very welcome therapeutic advance.”
Despite the fact that hepatitis C is curable, there is a pressing need for new and improved therapies because “many hepatitis C virus patients have not currently achieved a cure and often progress to end-stage liver disease or liver cancer,” he added.
Gilead notes that approximately nine million people in Europe are infected with hepatitis C virus, which is a major cause of liver cancer and liver transplantation.
EU approval of Sovaldi is also a boost for Bristol-Myers Squibb (BMS), which moved a step closer to approval of a combination regimen of sofosbuvir and its NS5A inhibitor daclatasvir earlier this year after the EMA’s Committee for Medicinal Products for Human use said the two drugs could be used on a compassionate basis in hepatitis C patients at high risk of liver failure or death.
BMS is hoping to position daclatasvir alongside sofosbuvir as the basis of an all-oral, interferon-free regimen of choice for hepatitis C.
Meanwhile, a host of other drugmakers are also vying for a share of the interferon-free market for hepatitis C, including Johnson & Johnson and Medivir, whose protease inhibitor Olysio (simeprevir) was cleared in the US in November 2013. The likes of AbbVie, Boehringer Ingelheim and Merck & Co all also have candidates in development.