Business Wire

European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes

Jaa

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 (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vosevi®, an investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients. The data included in the application support the use of SOF/VEL/VOX in patients with and without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen.

The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. The 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, Norway and Iceland.

The MAA for SOF/VEL/VOX is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4), evaluated 12 weeks of the single tablet regimen in patients with genotypes 1-6 HCV infection previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of SOF/VEL/VOX in DAA-naïve patients with genotypes 1-6 HCV infection. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with SOF/VEL/VOX (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with genotypes 1-6 HCV infection with and without cirrhosis treated with SOF/VEL/VOX (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse events among patients who received SOF/VEL/VOX in the POLARIS studies were headache, fatigue, diarrhea and nausea.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®, for use in combination with other agents. The single tablet regimen of sofosbuvir (400 mg) and ledipasvir (90 mg) received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®. The single tablet regimen of sofosbuvir (400 mg) and velpatasvir (100 mg) received marketing authorization in the European Union on July 8, 2016, under the trade name Epclusa®.

Gilead has also submitted a regulatory application for SOF/VEL/VOX in the United States. Gilead filed the New Drug Application for SOF/VEL/VOX on December 8, 2016, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act of August 8, 2017.

SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established and is not approved anywhere globally.

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. Gilead has operations in more than 40 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 the European Commission or other regulatory agencies, including the FDA, may not approve SOF/VEL/VOX for the treatment of chronic hepatitis C 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/VOX for chronic hepatitis C. 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 10Q for the quarter ended March 31, 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.

Full European Summary of Product Characteristics for Sovaldi, Harvoni and Epclusa are available from the EMA website at www.ema.europa.eu .

Vosevi, 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 or call Gilead Public Affairs at 1-650-574-3000.

Contact information

Gilead Sciences, Inc.
Investors
Sung Lee, +1 650-524-7792
or
Media (U.S.)
Mark Snyder, +1 650-522-6167
or
Media (Europe)
Arran Attridge, +44 (208) 587-2477

Tietoja julkaisijasta

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, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

The European Project AMable Launches Its First Open Call17.7.2018 11:00Tiedote

The European Project AMable has launched its First Open Call to find innovative ideas for additively manufactured products. The selected teams will be supported by AMable to develop an idea towards a final product by offering the services across all steps from design to finish. As a Factories of the Future (FoF) project participating in I4MS (ICT for Manufacturing SMEs) and with the support of the European Union's Horizon 2020 research and innovation programme, the aim of AMable project is to accelerate the uptake of additive manufacturing (AM) technologies; from design to manufacture for functional parts throughout the European Union. AMable is creating a digital framework to provide impartial access to the best European AM knowledge to support this adoption. This knowledge will be offered as advanced and tailored services to assist SMEs in the uptake of AM and include technological, business and training services. For this Open Call, the European Project is looking for original ideas

Norsk Titanium Marks Milestone in U.S. Production17.7.2018 10:00Tiedote

The University of Notre Dame Turbomachinery Laboratory (NDTL), Norsk Titanium US, Inc. (Norsk), Pratt & Whitney and TURBOCAM International are collaborating to develop and test additively manufactured turbomachinery components. This collaboration will focus on exploring the applicability of Norsk’s Rapid Plasma Deposition™ (RPD™) material to turbomachinery applications. As part of this effort, NDTL will test an additively manufactured integrally bladed rotor (IBR) produced and inspected to meet the applicable quality specifications used in Pratt & Whitney’s current turbomachinery components. The team has completed the initial phase of testing, with TURBOCAM International conducting machining trials of Norsk’s RPD™ material, and Pratt & Whitney successfully inspecting the material to the same specification as forged turbomachinery components. The material’s manufacturing qualities were evaluated for applicability to TURBOCAM’s precision milling processes. “We were very pleased with the

More Than Half of Sub-Saharan Africa to Be Connected to Mobile by 2025, Finds New GSMA Study17.7.2018 10:00Tiedote

More than half the population of Sub-Saharan Africa will be subscribed to a mobile service by 2025, according to the latest edition of the GSMA’s Mobile Economy report series, published at the GSMA ‘Mobile 360 – Africa’ event being held in Kigali this week. The new report forecasts that there will be 634 million unique mobile subscribers1 across Sub-Saharan Africa by 2025, equivalent to 52 per cent of the population, up from 444 million (44 per cent) at the end of last year. The report also calculates that the mobile ecosystem will add more than $150 billion in value to Sub-Saharan Africa’s economy by 2022, equivalent to almost 8 per cent of regional GDP. “For many citizens across the region, particularly those living in rural areas, a mobile phone is not just a communications device but also the primary channel for getting online and a vital tool for improving their lives,” commented John Giusti, Chief Regulatory Officer at the GSMA. “More needs to be done to extend connectivity to th

GSMA Finds That Consumers in Developing Countries Are Hard Hit by High Spectrum Prices17.7.2018 09:00Tiedote

Better spectrum pricing policies are needed in developing countries to improve the economic and social welfare of the billions of people that remain unconnected to mobile broadband services, according to a new report, ‘Spectrum Pricing in Developing Countries’, released by the GSMA today at the Mobile 360 – Africa conference in Kigali. The study reveals that spectrum prices in developing countries are, on average, more than three times higher than in developed countries, when income is taken into account. This high spectrum pricing is a major roadblock to increasing mobile penetration. Authored by GSMA Intelligence, the study also found that governments are playing an active role in increasing spectrum prices to maximise state revenues from spectrum licensing. High spectrum prices are linked to countries with high levels of sovereign debt, and alarmingly average reserve prices in spectrum auctions are more than five times higher in developing countries than in developed, once income is

NEC and dotData Use AI to Accelerate Data Science for the SMBC Group17.7.2018 07:38Tiedote

NEC Corporation (NEC) (TOKYO:6701) and dotData, Inc., a Silicon Valley venture in the automation of data science, today announced the provision and full operation of “dotData” platform for the Sumitomo Mitsui Financial Group, Inc. (SMBC Group) in order to strengthen the Group’s analytical capabilities. In recent years, the need for big data analytics has been growing rapidly. However, there is also an increasing shortage of data scientists to handle this need. In order to address this issue, dotData automates data science processes through artificial intelligence (AI). dotData platform is now commercially available globally. NEC has obtained an exclusive license from dotData to provide this software across Japan. Sumitomo Mitsui Banking Corporation, NEC and the dotData team have actively worked to incorporate AI into banking operations in order to create new service offerings since 2016. Following this success, the SMBC Group is now expanding the provision of dotData platform throughou

Cushman & Wakefield To Acquire Its Irish Affiliate From Sherry FitzGerald Group16.7.2018 16:49Tiedote

Global real estate services firm Cushman & Wakefield today announces it has entered into a definitive agreement to acquire the commercial property arm of Sherry FitzGerald Group in the Republic of Ireland. The deal is expected to complete in early September 2018. Cushman & Wakefield already has a 20% stake in the Irish commercial property business which operated as its exclusive affiliate in the Republic – rebranding two years ago as Cushman & Wakefield Ireland. The firm, which has more than 100 commercial property professionals and offices in Dublin, Limerick and Galway, will now be fully integrated into Cushman & Wakefield, one of the world’s largest real estate services firms with 48,000 employees in approximately 400 offices and 70 countries. Managing Director Aidan Gavin becomes Cushman & Wakefield’s Head of Ireland and will also sit on the firm’s UK & Ireland Executive Committee. Cushman & Wakefield will maintain its close affiliate relationship with the wider Sherry FitzGerald G

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