Gilead's Hepatitis C Treatment Sofosbuvir Gets European Commission Nod
Gilead Sciences’ Sofosbuvir, a hepatitis C treatment potentially faster and more effective than current therapies, has been approved by the European Commission. The European Commission approval predicates marketing rights for Gilead in all European Union countries including European Economic Area countries Iceland, Norway, and Liechtenstein.
Sofosbuvir is a nucleotide analogue inhibitor that can be used by adult patients with any of the six variations of hepatitis C. When used with standard treatments such as Ribavirin (RBV) tablets, sofosbuvir showed high cure rates of up to 90% in patients who have not yet been treated. Gilead will market the drug in 400mg tablets across the EU.
Standard treatment for hepatitis C requires up to 48 weeks of peg-interferon (peg-IFN) injection and Ribavirin (RBV) tablets therapy. The length of the therapy period is a common barrier to patient treatments. Moreover, patients using peg-IFN may experience symptoms similar to flu along with bone marrow suppression and abdominal pains. RBV side effects include tiredness and anemia among others. If untreated, hepatitis C could lead to liver cancer or liver transplants.
Professor of hepatology Dr. Graham Foster at Queen Mary University in London said, “Unlike many chronic diseases, hepatitis C can be cured. For many hepatitis C patients, however, for a number of reasons, many hepatitis C patients have not currently achieved a cure and often progress to end-stage liver disease or liver cancer.”
Dr. Foster said sofosbuvir will increase the number of cured hepatitis C patients. “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.”
Gilead has already won FDA approval for its drug Sovaldi last December. The company is currently seeking approval in Turkey, Australia, New Zealand, and Switzerland.