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news.Gilead Sciences has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for marketing authorization application (MAA) of Harvoni, an investigational once-daily tablet, to treat chronic hepatitis C virus (HCV) infection in adults.
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Harvoni is a combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg.
The European Commission, which has the authority to approve medicines for use in the 28 countries of the EU, will now review CHMP’s recommendation.
The positive opinion was based on data from three Phase III trials ION-1, ION-2 and ION-3, which evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, in about 2,000 genotype 1 HCV patients with compensated liver disease.
The trials included cirrhotic and non-cirrhotic patients who were new to HCV treatment and those who had failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
The CHMP positive opinion was also supported by preliminary data from the SOLAR-1 trial in decompensated cirrhotic and pre- and post-transplant patients, the ELECTRON-2 trial in genotype 3 patients and Phase II studies in genotype 4 patients.