Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.
The NDA is supported by data from four Phase 3 studies that evaluated the fixed-dose combination among treatment-naïve patients and among virologically suppressed patients. A marketing application for BIC/FTC/TAF is also under review in the European Union, and was validated by the European Medicines Agency (EMA) in July. Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious 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. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
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 possibility that FDA and other regulatory authorities may not approve BIC/FTC/TAF in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on their use. As a result, BIC/FTC/TAF may never be successfully commercialized. 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.
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 (Investors)
Kelsey Grossman, 650-378-2103 (Media)
Om Business Wire
(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
Nearly 1 Billion People Worldwide Have Sleep Apnea, International Sleep Experts Estimate21.5.2018 18:15 | Pressemelding
A new data analysis presented by ResMed (NYSE: RMD, ASX: RMD) this week at the ATS 2018 International Conference indicates that the prevalence of sleep apnea impacts more than 936 million people worldwide – nearly 10 times greater than previous estimates. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005096/en/ Woman wearing CPAP, the gold standard treatment for sleep apnea (Photo: Business Wire) The study “Global Prevalence of Obstructive Sleep Apnea (OSA)” was conducted by an international panel of leading researchers seeking to provide a clear scope of the impact of the chronic sleep-disordered breathing condition. The previous estimation of OSA prevalence (100 million) came from a 2007 World Health Organization study that used methods and data available at the time. By analyzing technology improvements in detecting OSA and underreported statistics from other areas of the world, this latest study depicts an impacte
Pietro Rosa TBM Signs Long-Term Agreement with Pratt & Whitney21.5.2018 15:13 | Pressemelding
Pietro Rosa TBM (Turbine Blade Manufacturing) today announced that it has signed a 10-year, long-term agreement (LTA) with Pratt & Whitney, a division of United Technologies Corp., to supply airfoil products for both commercial and military engines. The LTA, which may extend to the entire Pietro Rosa TBM Group in Europe and the United States, will support Pratt & Whitney’s F135, PW2000 and the Geared Turbofan™ (GTF) family of engines. This agreement represents a significant step in the collaboration between the two companies, enabling the Pietro Rosa TBM Group to utilize its advanced engineering capabilities and the vertical integration of hot forming, machining and surface finishing technologies. “We’re pleased to sign this agreement with Pietro Rosa,” said Art Erikson, executive director of Strategic Sourcing, Pratt & Whitney. “We have tremendous growth ahead, and suppliers like Pietro Rosa that sign up to our contractual governance, commitment to cost competitiveness and continuous
NioCorp Awards Contract to Rockwell Automation on Groundbreaking Critical Minerals, Mining and Processing Facility in Nebraska21.5.2018 12:00 | Pressemelding
NioCorp Developments Ltd. (TSX: NB, OTCQX: NIOBF), a developer of superalloy metals, has awarded a major contract to Rockwell Automation (NYSE: ROK) to engineer, design and procure process automation and instrumentation for NioCorp’s proposed critical minerals, mining and processing facility in Elk Creek, Nebraska. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005228/en/ Three superalloy metals – niobium, scandium and titanium – are expected to be produced by the facility as early as 2021. These critical materials are used in the aerospace, defense, automotive, clean energy, commercial aviation and mega-infrastructure sectors. Generally, these superalloys enable increased strength and lighter weight in transportation and other systems, leading to better fuel efficiency and lower greenhouse gas and other air emissions, according to NioCorp. “We selected Rockwell Automation and its partners to automate our process equip
Ultra-Low Power Lattice sensAI Leads Mass Market Enablement of Artificial Intelligence in Edge Devices21.5.2018 12:00 | Pressemelding
Lattice Semiconductor Corporation (NASDAQ: LSCC) today unveiled Lattice sensAI™ – a complete technology stack combining modular hardware kits, neural network IP cores, software tools, reference designs and custom design services – to accelerate integration of machine learning inferencing into broad market IoT applications. With solutions optimized for ultra-low power consumption (under 1 mW–1 W), small package size (5.5 mm2 –100 mm2), interface flexibility (MIPI® CSI-2, LVDS, GigE, etc.), and high-volume pricing (~$1-$10 USD), Lattice sensAI stack fast-tracks implementation of edge computing close to the source of data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005011/en/ (Graphic: Business Wire) “Lattice sensAI addresses the unmet need for flexible, low cost, ultra-low power AI silicon solutions suited for rapid deployment across a wide range of emerging, mass market IoT applications,” said Deepak Boppana, senior
Biosimilars could facilitate early access to life changing biological treatments for patients says Celltrion Healthcare21.5.2018 11:27 | Pressemelding
At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Celltrion Healthcare today advocated for healthcare systems to introduce biologics earlier in a patient’s treatment regimen in order to improve clinical outcomes. Several studies show that the early introduction of biologics can bring greater clinical benefit to patients.1,2,3,4,5,6 However, only a limited number of patients have access to biological treatment due to the high-cost of biologics and current reimbursement policies determined by pharmacoeconomic evaluations. Since the introduction of biosimilars, the overall cost of biological treatments has reduced in Europe, allowing an increased number of patients to access this important treatment option earlier in their course of treatment.7 Professor Jørgen Jahnsen said, “For the treatment of inflammatory bowel disease, biological treatments are proven to be the most efficacious medical therapy and their ea
Dole’s Joint Venture Recycling Company Celebrates 25 Years21.5.2018 11:00 | Pressemelding
Dole Food Company announced today that Recyplast S.A., an innovative plastic recycling company based in Costa Rica and with joint ownership including a subsidiary of Dole Fresh Fruit, recently surpassed 25 years in its mission to dramatically reduce and reuse agricultural waste. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180521005160/en/ Raul Martinez (right), General Manager of Dole Standard Fruit de Costa Rica, receives a plaque from Jose Miguel Ramirez, General Manager of Recyplast, in recognition of the contribution of Dole's banana plantations in the correct handling, storage, and provision of field plastic waste. The plastic recycling facility pioneered the collection of field plastics after use in banana growing operations in Costa Rica. This reuse and recycling process includes reclamation of plastic bags that protect bananas from weather and insects, as well as the collection of plastic twine used to prop the ba