FOSTER CITY, Calif.–(BUSINESS WIRE)–Sep. 26, 2014–
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
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.
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