CHMP recommends Harvoni for for the treatment of Chronic Hepatitis C - Gilead Sciences

Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company�s Marketing Authorization Application (MAA) for Harvoni, an investigational once-daily tablet combining the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of Chronic Hepatitis C virus (HCV) infection in adults.

The CHMP positive opinion for Harvoni is supported by data from three Phase III studies (ION-1, ION-2 and ION-3). These studies evaluated 8, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies 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 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.