European CHMP adopts positive opinion for Gilead’s Harvoni® (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C infection in adults

Gilead Sciences, Inc. (Nasdaq: GILD) today 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 opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of major public health interest.  The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union.

The CHMP positive opinion for Harvoni is supported by data from three Phase 3 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 2 studies in genotype 4 patients.

Approximately nine million people in Europe are infected with the hepatitis C virus, a major cause of liver cancer and liver transplantation.  Genotype 1 is the most prevalent form of HCV in Europe, and accounts for 60 percent of infections worldwide. This is followed by genotypes 2 and 3, while genotypes 4-6 are more prevalent in Asia and Africa.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi^®.  Sovaldi is also approved for use in the United States, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.

Harvoni is an investigational product and its safety and efficacy have not been established in the European Union.