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Gilead Sciences receives EU approval for Sovaldi
Gilead Sciences has announced that its new hepatitis C therapy Sovaldi has been approved by the European Commission.
The regulatory body has ratified the once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C infections in adults, when used in combination with other antiviral agents and pegylated interferon alpha.
Data from four phase III studies has demonstrated the efficacy of Sovaldi in patients with hepatitis C genotypes 1-4, in those awaiting liver transplantation and those with hepatitis/HIV co-infection.
It is hoped that the launch of Sovaldi will make it possible for more European patients to be cured of the disease.
Dr John Martin, chairman and chief executive officer of Gilead Sciences, said: "We are committed to working with local governments and health systems to make Sovaldi available in Europe as quickly as possible."
This comes after the company received EU approval for the HIV therapy Vitekta in November 2013.
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