China Food and Drug Administration Approves Gilead’s Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection
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 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.
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.
- 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.
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.
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.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Sonia Choi, 650-425-5483
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
LIAF: Experts at the European Parlament - E-Cigarettes Are a Potential Game Changer for European Health20.3.2018 21:27 | Tiedote
The following is a statement from LIAF – Lega Italiana Anti Fumo: The panel discussion at the EU Parliament recognises the potential benefits of electronic cigarettes and for European countries to treat these products as regular consumer products to ensure equal access for all Europeans. Following a debate in which leading scientific experts presented the state-of-the-art evidence around e-cigarettes, it became clear that public health is increasingly moving on from an approach that solely advocates ‘quit-or-die’ to a harm reduction strategy. “I’m glad to have brought the Parliament attention to this important issue for public health. Today we have listened to the results of scientific studies and researches from a high-level expert’s roundtable, which have illustrated to us the advantages of electronic cigarettes and the potential public health benefits that these products pose when compared to the conventional cigarettes. As decision-makers, we need to take into considerations these
Morinaga Milk's New Probiotic Strain, Bifidobacterium breve A1, May Prevent Onset of Alzheimer's Disease20.3.2018 21:00 | Tiedote
Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company, today announced the results of a new study investigating the preventive effects of its new probiotic strain Bifidobacterium breve A1 on a model of Alzheimer’s disease. Researchers found that B. breve A1 improved spatial recognition capability, as well as learning and memory capabilities, in cognitively deficient mice, indicating it could play an important role in preventing the onset of Alzheimer’s Disease in humans.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320005052/en/ (Fig. 1) Effects of B. Breve A1 in improving spatial recognition, learning and memory capabilities (Graphic: Business Wire) The number of patients affected by dementia is increasing worldwide. One report estimates there were 46.8 million people worldwide living with dementia in 2015 and projects this number will reach 131.5 million by 2050.2 Alzheimer’s disease
Dubai Breaks Ground on World’s Biggest CSP Project20.3.2018 19:10 | Tiedote
HH Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, broke ground on the 4th phase of the Mohammed bin Rashid Al Maktoum Solar Park. This is the biggest Concentrated Solar Power (CSP) investment project in the world, based on the Independent Power Producer (IPP) model, and will generate 700MW on a single site. It will have the world’s tallest solar tower at 260 metres, and the largest thermal energy storage capacity in the world. It will provide clean energy to 270,000 residences, reducing 1.4 million tonnes of carbon emissions annually. The project will use two technologies: a 600MW parabolic basin complex and a 100MW solar tower, over 43 square kilometres. This project, with AED14.2 billion in investments, achieved the lowest Levelised Cost of Electricity (LCOE) of USD 7.3 cents per kW/h. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320006214/en/ Dubai breaks groun
Edgecore Networks Introduces 400G Open Networking20.3.2018 19:00 | Tiedote
OCP Summit – Edgecore Networks, the leader in open networking, today announced its contribution to the Open Compute Project (OCP) of the design of a 400 Gigabit Ethernet (400G) data center switch, the industry’s first 400G open design, that will enable public and private network operators to increase dramatically the capacity of their infrastructures. “Four years ago, Edgecore contributed the industry’s first OCP-ACCEPTED™ network product, a 10G top-of-rack switch,” said George Tchaparian, CEO, Edgecore Networks. “Since then, we have contributed over 15 network product designs as open networking technology and deployments grew to include 25G/100G data center fabrics, deep-buffer data center interconnect switches, service provider access infrastructures, open modular chassis, and campus/branch/wireless networks. Now, Edgecore is introducing the industry’s first 400G open network switch, enabling network operators to respond to growing demands for network capacity, and increasing the ban
Technics Organizes World's First Full Turntable Orchestra20.3.2018 17:48 | Tiedote
On March 20, 2018, the "Record Day," Panasonic Corporation released the video of the world's first full orchestra performance featuring Technics "turntables (analog record players)" as the only instruments, under the Technics brand's theme, "Rediscover Music." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320006023/en/ World's First Full Turntable Orchestra organized by Technics (Photo: Business Wire) Videos: - THE PHILHARMONIC TURNTABLE ORCHESTRA https://youtu.be/JGWuyMKT8wU - BEHIND THE BEATS : THE PHILHARMONIC TURNTABLE ORCHESTRA https://youtu.be/J2KK3vqJqog "The Philharmonic Turntable Orchestra" special website Thirty renowned DJs from around the world, including DJ Rena, the reigning Japanese world champion (youngest ever world champion in history), who took the "DMC World Championship" title in 2017 at just 12 years old*, came together to create the world's first "turntable orchestra." Using the Technics' iconic tu
Bentley Systems' Year in Infrastructure 2018 Conference and Awards Gala to be Held in London, Oct. 15-1820.3.2018 17:30 | Tiedote
Bentley Systems, Incorporated, a leading global provider of comprehensive software solutions for advancing infrastructure, today announced that the Year in Infrastructure 2018 Conference will be held Oct. 15 through 18 in London at the Hilton London Metropole. Presented by Bentley Institute, the conference is a global gathering of leading industry executives and prominent thought leaders in the design, construction, and operations of the world’s infrastructure. The theme of this year’s conference is Going Digital: Advancements in Infrastructure. The conference features nearly 70 speakers and more than 50 informative sessions, including keynotes by leading industry experts, interactive workshops, forums, panel discussions, and product demonstrations. Attendees can visit the Technology Pavilion, which features exhibits and presentations from Bentley Systems and its strategic partners Microsoft, Siemens, Topcon, and Bureau Veritas. On the first day of the conference, Bentley Institute wil
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme