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European CHMP Adopts Positive Opinion for Gilead's Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults
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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 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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the MAA may not be approved by the European Commission, and marketing approval, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
<1>Sovaldi and Harvoni are registered trademarks of Gilead Sciences, Inc., or its related companies
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at +1 (650) 574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O'Brien, +1 650-522-1936 (Investors)
Cara Miller, +1 650-522-1616 (Media, U.S.)
Arran Attridge, +44 208 587 2477 (Media, EU)
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