Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating a Once-Daily, Fixed-Dose Combination of Sofosbuvir (SOF) and Velpatasvir (VEL) (GS-5816) for the Treatment of All Six Hepatitis C Genotypes - (09/22/15)
Gilead Submits New Drug Application to U.S. Foodand Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir (GS-5816) for Treatment of All Six Genotypes of Hepatitis C
-- If Approved, Combination Would Be FirstAll-Oral, Pan-Genotypic Single-Tablet Regimen for Chronic HCV Infection -- -- Filing is Company’s Third in Three Years for aNew HCV Medicine -- FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 28,2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it hassubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration(FDA) for an investigational, once-daily fixed-dose combination of thenucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi®in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5Ainhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV)infection. The NDA is supported by clinical studies exploring the use of 12weeks of SOF/VEL for patients with genotype 1-6 HCV infection, includingpatients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin forpatients with decompensated cirrhosis. “As the first fixed-dose combination of twopan-genotypic, direct-acting antivirals, SOF/VEL represents an important stepforward in the treatment of patients with hepatitis C,” said NorbertBischofberger, PhD, Executive Vice President of Research and Development andChief Scientific Officer at Gilead. “Genotype 1 is the most prevalent form ofHCV in the United States, but worldwide, more than half of people living withHCV are infected with other genotypes. SOF/VEL complements our current HCVportfolio of Sovaldi and Harvoni, offering high cure rates and the potential tosimplify treatment and eliminate the need for HCV genotype testing.” The FDA has assigned SOF/VEL a Breakthrough Therapydesignation, which is granted to investigational medicines that may offer majoradvances in treatment over existing options. The NDA for SOF/VEL is supportedby data from four Phase 3 ASTRAL trials, which evaluated the fixed-dosecombination in hepatitis C genotypes 1-6. Of the 1,035 patients treated withSOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 studyrandomized 267 patients with decompensated cirrhosis (Child-Pugh class B) toreceive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks ofSOF/VEL. Those who received SOF/VEL plus RBV for 12 weeks achieved an SVR12rate of 94 percent, while those who received SOF/VEL for 12 weeks and 24 weeksachieved SVR12 rates of 83 percent and 86 percent, respectively. Patients treated with SOF/VEL for 12 weeks inASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared withplacebo-treated patients in ASTRAL-1. The most common adverse events wereheadache, fatigue and nausea. The most common adverse events in ASTRAL-4 werefatigue, nausea and headache. Gilead plans to submit a regulatory application forapproval of SOF/VEL in the European Union by the end of the year. The SOF/VEL fixed-dose combination is aninvestigational product and its safety and efficacy have not been established. About Gilead Sciences Gilead Sciences is a biopharmaceutical company thatdiscovers, develops and commercializes innovative therapeutics in areas ofunmet medical need. The company’s mission is to advance the care of patientssuffering from life-threatening diseases. Gilead has operations in more than 30countries worldwide, with headquarters in Foster City, California. Forward-Looking Statement This press release includes forward-lookingstatements within the meaning of the Private Securities Litigation Reform Actof 1995 that are subject to risks, uncertainties and other factors, includingthe risk that FDA may not approve the SOF/VEL fixed-dose combination, and thatany marketing approvals, if granted, may have significant limitations on itsuse. In addition, Gilead may be unable to file for regulatory approval ofSOF/VEL in other geographies in the currently anticipated timelines. Further,additional clinical studies of SOF/VEL may produce unfavorable results. As aresult, Gilead may not be able to successfully commercialize SOF/VEL. Theserisks, uncertainties and other factors could cause actual results to differmaterially from those referred to in the forward-looking statements. The readeris cautioned not to rely on these forward-looking statements. These and otherrisks are described in detail in Gilead’s Quarterly Report on Form 10-Q for thequarter ended June 30, 2015, as filed with the U.S. Securities and ExchangeCommission. All forward-looking statements are based on information currentlyavailable to Gilead, and Gilead assumes no obligation to update any suchforward-looking statements. U.S. full prescribing information for Sovaldi andHarvoni is available at www.gilead.com. Sovaldi and Harvoni are registered trademarks ofGilead 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 1-800-GILEAD-5 or1-650-574-3000. View source version on businesswire.com: http://www.businesswire.com/news/home/20151028006842/en/ Source: Gilead Sciences, Inc. Gilead Sciences, Inc.
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发表于 2015-10-30 13:47