European Commission has granted marketing authorization for Sovaldi® (sofosbuvir)
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17.01.2014

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FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 17, 2014-- Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Sovaldi® (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha (peg-IFN)). Today’s marketing authorization follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest, and allows for the marketing of Sovaldi in all 28 countries of the European Union (EU). Sovaldi has been studied in hepatitis C virus (HCV) genotypes 1-6. The efficacy of Sovaldi has been established in patients with genotypes 1-4, in those awaiting liver transplantation and those with HCV/HIV-1 co-infection. The clinical data supporting the use of Sovaldi in patients with genotypes 5 and 6 is limited
Monotherapy is not recommended.
“Unlike many chronic diseases, hepatitis C can be cured. However, for a number of reasons, many HCV patients have not currently achieved a cure and often progress to end-stage liver disease or liver cancer,” said Graham Foster, MD, Professor of Hepatology, Queen Mary University of London. “With high cure rates across a broad range of patients and a short duration of therapy, Sovaldi is a very welcome therapeutic advance that will increase the number of patients who can be treated and ultimately cured.” Approximately nine million people in Europe are infected with HCV, a major cause of liver cancer and liver transplantation. The societal, clinical and economic burden of untreated HCV is substantial, with HCV-related healthcare costs directly related to disease severity. The current standard of care for HCV involves up to 48 weeks of therapy with a peg-IFN/RBV-containing regimen, which may not be suitable for certain types of patients. “The marketing authorization of Sovaldi is an important step forward in the management of hepatitis C in Europe, enabling many more patients the opportunity of cure,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “We are committed to working with local governments and health systems to make Sovaldi available in Europe as quickly as possible.”
See more at: http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1891746&highlight#sthash.ZWXWnZ5j.dpuf