Business Wire

China Food and Drug Administration Approves Gilead’s Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection

Del

Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.

The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting. SVR12 (HCV RNA undetectable 12 weeks after completing therapy) rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged from 92-100 percent. The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis. In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin. The most common adverse events were hematological abnormalities and pyrexia.

Professor Lai Wei, the principal investigator of Sovaldi’s Phase 3 study and former Chairman of the Chinese Society of Hepatology of the Chinese Medical Association said, “The approval of sofosbuvir in China provides more treatment options for Chinese HCV patients. The clinical trials in China and around the world provide evidence that the treatment is effective for multiple genotypes, which offers HCV patients in China a better chance at curing their disease.”

HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected. HCV genotypes 1, 2, 3 and 6 account for more than 96 percent of all cases. Less than one percent of HCV patients are currently treated, using interferon-based regimens that have lower efficacy, longer treatment duration and less favorable safety profiles than more recent regimens that contain direct-acting antiviral medicines.

“With the approval of Sovaldi, there is now the potential opportunity to transform treatment for HCV patients in China,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “Medicines are one part of the solution but, as we have seen in other countries around the world, there are many other challenges that impact diagnosis, linkage to care and treatment. Gilead is committed to working with the government and other stakeholders with the goal to help reduce the significant burden of HCV disease in China.”

Sovaldi received marketing approval from the U.S. Food and Drug Administration (FDA) in 2013 and the European Commission in 2014. It is also approved for use in 79 countries including Australia, India, Indonesia, the Philippines, New Zealand, Canada, Egypt, Switzerland and Turkey.

Gilead Sciences in China

Gilead has been present in China since 2007, starting with manufacturing and growing over time to include the establishment of commercial operations based in Shanghai in 2016.

Beyond the approval of Sovaldi, Gilead is studying its HCV single-tablet regimens Harvoni® (ledipasvir/sofosbuvir) and Epclusa® (sofosbuvir/velpatasvir) at clinical trials sites across China, with the aim of providing important new treatment options to Chinese HCV patients.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SOVALDI IN U.S.

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with SOVALDI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents.

Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and posttreatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Contraindications

  • Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the Prescribing Information for peginterferon alfa and ribavirin for a list of their contraindications.

Warnings and Precautions

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with SOVALDI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers: Rifampin and St. John's wort are not recommended for use with SOVALDI as they may significantly decrease sofosbuvir plasma concentrations.
  • Risk Associated with Combination Treatment: Because SOVALDI is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.

Adverse Reactions

Most common adverse reactions (≥20%, all grades) for:

  • SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia.
  • SOVALDI + ribavirin combination therapy were fatigue and headache.

Drug Interactions

  • In addition to rifampin and St. John's wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.

Indication:

SOVALDI is indicated for the treatment of chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen:

  • genotype (GT) 1 or 4 infected adults without cirrhosis or with compensated cirrhosis, in combination with pegylated interferon and ribavirin.
  • GT 2 or 3 infected patients at least 12 years of age (or ≥35 kg) without cirrhosis or with compensated cirrhosis, in combination with ribavirin.

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.

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 physicians in China may not see the benefits of prescribing Sovaldi for the treatment HCV infection. 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, 2017, 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.

U.S. Full Prescribing Information for Sovaldi, including BOXED WARNING is available at www.gilead.com

SOVALDI, HARVONI and EPCLUSA 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 1-800-GILEAD-5 or 1-650-574-3000.

Contact information

Gilead Sciences, Inc.
Investors
Sung Lee, 650-524-7792
or
Media
Sonia Choi, 650-425-5483

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Vertex Initiates First Phase 3 Study of VX-659, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis21.2.2018 21:01Pressemelding

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it is initiating the first Phase 3 study of VX-659, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation. The study will enroll 360 patients, and the primary endpoint of the study is the mean absolute change from baseline in percent predicted forced expiratory volume in one second (ppFEV1) at week four of treatment. The study is designed to support the submission of a New Drug Application (NDA) in the U.S. using data from the 4-week primary efficacy endpoint together with safety data through 12 weeks of treatment. “Our goal is to bring the best triple combination to patients as rapidly as possible, and this first Phase 3 study of VX-659 in combination with tezacaftor and ivacaftor is a significant step toward that goal,” said Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical

Universal Laser Systems® Expands Portfolio of Laser Material Processing Systems with the ULTRA Platform Series21.2.2018 18:00Pressemelding

ULTRA platform-based laser systems are designed and ideally suited for precision laser cutting, laser ablation, and laser surface modification in manufacturing, research and development, academic research and prototyping environments. Major features of the series include rapid, high-accuracy laser beam positioning, and the flexibility to be configured with 9.3 and 10.6 µm CO2 lasers and 1.06 µm fiber lasers. All lasers are air-cooled in a range of power from 10 to 150 watts for CO2 and 40 to 50 watts for fiber lasers. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005364/en/ The ULTRA 9MW offers MultiWave processing of thin materials. (Photo: Business Wire) The variety of wavelengths and power ranges make the ULTRA platforms highly effective in the areas of organic material modification, including plastic films, industrial fabrics, engineering plastics, laminating adhesives, composite materials, and many others utilized

Luxoft One of Six Companies Collaborating with Amazon Web Services to Accelerate Blockchain Adoption21.2.2018 16:30Pressemelding

Luxoft Holding Inc (NYSE:LXFT), a global IT service provider, announces today that it is collaborating with Amazon Web Services (AWS) to enable corporates to adopt blockchain and Distributed Ledger Technologies (DLT). Luxoft is one of six IT and consulting services companies to make its blockchain advisory and development services available to AWS users. “We are very excited to be working with AWS to help users engage with blockchain and DLTs,” said Vasiliy Suvorov, Vice President of Technology Strategy at Luxoft. “Blockchain is about removing data silos, improving trust and operational efficiencies. By using AWS to deploy and integrate DLTs into day-to-day processes, businesses can revolutionize how they operate.” Luxoft helps accelerate the deployment and integration of blockchain and DLT-based projects on AWS and is already working on a number of DLT projects using the cloud. For example, Luxoft is building a healthcare claims processing system for a leading healthcare provider usin

Westinghouse Electric Company to Provide Engineering Support at Vandellós 1 in Partnership with EDF21.2.2018 16:30Pressemelding

Westinghouse Electric Company and Electricité de France (EDF), in partnership, announced today that they have been awarded a contract from Empresa Nacional de Residuos Radiactivos (ENRESA), the Spanish agency responsible for radioactive waste management and nuclear plant decommissioning. The agreement covers a four-year engineering support contract for the latency phase of the dismantling and decommissioning project at Vandellós I Nuclear Power Station in Spain and includes the preparation of technical and licensing documentation. “We are extremely pleased that ENRESA has selected Westinghouse and EDF to continue supporting the decommissioning activities at Vandellós I Nuclear Power Station,” said Yves Brachet, Westinghouse vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “This contract further demonstrates Westinghouse’s global capabilities and expertise in providing innovative decommissioning solutions.” Sylvain Granger, head of EDF's decommi

H.I.G. Europe Completes a Strategic Investment in Puerto de Indias Group21.2.2018 14:02Pressemelding

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €20 billion of equity capital under management, announced that one of its affiliates has acquired a majority interest in Puerto de Indias Group (“Puerto de Indias” or the “Company”), with the goal of accelerating the Company’s growth initiatives and supporting its expansion into international markets. Headquartered in Seville, Spain, Puerto de Indias was founded by Jose Antonio and Francisco Rodriguez Fernandez, and has become in a short period of time the leading player in the Rosé Gin market in Spain. Puerto de Indias has in place an ambitious international expansion plan targeting the development of a commercial network in Europe, the U.S., and Latin America, as well as strategic alliances with strong international distributors. Leopoldo Reaño, Principal at H.I.G. Europe, commented on the transaction: “We are thrilled to have the opportunity to support the management team led by Jose Antonio an

Savi Adds Supply Chain Star Johannes Giloth to Advisory Board21.2.2018 13:02Pressemelding

Savi®, an innovator in big data/machine learning analytic solutions, supply chain management software, and sensor technology, today announced that Johannes Giloth has joined its board of advisers. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005117/en/ Johannes Giloth (Photo: Business Wire) Giloth is a long-time leader in procurement, supply chain and manufacturing. He currently serves as Chief Procurement Officer and Senior Vice President of Operations at Nokia where he is in charge of every aspect of operations accountability worldwide — from demand planning to execution, procurement to manufacturing. “Johannes understands the impact the explosion of data will have on the supply chain. And his tremendous success as an innovative supply chain leader proves he knows what companies need to transform their supply chains,” said Rich Carlson, CEO of Savi Technology. “I’m thrilled to have him join Savi’s advisory board. As