European Medicines Agency Validates Gilead's Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that its Marketing Authorization Application (MAA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on November 17, 2015, support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.
"Despite advances in the treatment of HCV, there is a need for simple, highly effective pan-genotypic therapies, particularly for patients with genotype 3 HCV infection, who traditionally have been more difficult to cure," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. "If approved, SOF/VEL will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes."
The MAA for SOF/VEL is supported by four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Ninety-four percent of patients who received SOF/VEL plus RBV for 12 weeks achieved an SVR12, while 83 percent and 86 percent of patients who received SOF/VEL for 12 weeks and 24 weeks, respectively, achieved SVR12. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2015, and were also published in The New England Journal of Medicine.
Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared with placebo-treated patients in ASTRAL-1. The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea.
SOF/VEL is the third investigational medicinal product from Gilead for HCV infection to receive Accelerated Assessment by the EMA. This, however, does not assure a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. Review of the MAA will be conducted under the centralized licensing procedure, which, if authorized, provides marketing authorization in all 28 member states of the European Union, Norway and Iceland. If approved, SOF/VEL could be available for marketing in the European Union in 2016. Gilead has also submitted a regulatory application for SOF/VEL in the United States.
SOF/VEL is an investigational product and its safety and efficacy has not yet been established.
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. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
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 European Commission or other regulatory agencies may not approve SOF/VEL, and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize SOF/VEL. 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 September 30, 2015, 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.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at +44 (208) 587-2477.
Gilead Sciences, Inc.
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