Gilead Sciences Receives EU Approval for Hepatitis C Combination Drug

The European Commission has granted marketing authorization for Gilead Sciences’  combination therapy, Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), a once-daily single tablet regimen to treat the majority of chronic hepatitis C Genotype 1 and 4 infection in adults. Harvoni combines the NS5A inhibitor, ledipasvir, with the nucleotide analog polymerase inhibitor, sofosbuvir. Sofosbuvir, the active ingredient in Gilead’s top-selling drug, Sovaldi, was approved by the European Commission in January 2014 and by the US Food and Drug Administration (FDA) in December 2013. Sovaldi posted sales of $8.55 billionfor the first nine months of 2014.

Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and is recommended in treatment-naïve and treatment-experienced cirrhotic and non-cirrhotic Genotype 1 and 4 patients with a treatment duration of 12 or 24 weeks depending on prior treatment history and cirrhosis status. Eight weeks of treatment with Harvoni may be considered in non-cirrhotic treatment-naïve genotype 1 patients. In Genotype 1 and 4 patients with decompensated cirrhosis, and Genotype 3 patients with cirrhosis and/or prior treatment failure, Harvoni should be used in combination with ribavirin for 24 weeks. Harvoni is also indicated for patients with HCV who have HIV co-infection.

Harvoni was approved by the FDA and Health Canada in October 2014 and in New Zealand in November 2014. Regulatory submissions for Harvoni are pending in Japan and Switzerland. Sovaldi as a single agent is approved for use in the European Union and in the United States, Canada, Australia, New Zealand, Egypt, Switzerland, and Turkey.

Source: Gilead Sciences

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