European CHMP Adopts Positive Opinion for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide)
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 Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.
BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone.
“Triple therapy has been the standard of HIV treatment for more than 20 years and has allowed people living with HIV to achieve durable undetectability. At Gilead, we have continued to explore ways to improve and provide more HIV treatment options, with the goal of going beyond reducing viral load and helping to address some of the wider challenges faced by people living with HIV,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. “If approved, Biktarvy would be the fifth TAF-based product for HIV in the European Union in the past three years, and because of its drug interaction profile, minimal monitoring requirements and ease of administration we believe it could represent a meaningful advance in HIV treatment for appropriate patients in Europe.”
The MAA for BIC/FTC/TAF is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,415 participants. BIC/FTC/TAF met its primary objective of non-inferiority at 48 weeks in all four studies.
The CHMP’s 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, Iceland and Liechtenstein. A European Commission decision is expected in mid-2018.
BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018.
In the European Union, BIC/FTC/TAF is an investigational product and its efficacy and safety have not yet been established.
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 35 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 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 generic 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 risk that the European Commission may not approve BIC/FTC/TAF in the currently anticipated timelines or at all, and any marketing approval, if granted, may have significant limitations on its use. 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 Annual Report on Form 10-K for the year ended December 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.
Biktarvy, Descovy, Gilead and the Gilead logo are 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
Ryan McKeel, 650-377-3548
Stephen Head, +44 (0)7768 705945
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
Kristen Lisanti Joins BCW as Chief Culture Officer18.10.2018 17:17 | Pressemelding
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Kristen Lisanti has joined the firm as Chief Culture Officer, responsible for establishing an engaging culture at BCW that honors the diversity of its people and connects them through deep values, a global passion for the agency’s business and a fresh, new approach to employee satisfaction. In addition to driving employee engagement and building a global training program, Lisanti, based in New York, will be charged with establishing BCW as a best place to work around the world. “The culture of any organization is a critical pillar to its success,” said Donna Imperato, Global CEO, BCW, to whom Lisanti reports. “I’ve always focused on creating and nurturing the right culture. It doesn’t happen by itself and it requires just as much attention as other business aspects of an organization. BCW will be among the first in our industry to hire a global Chief Culture Officer whose sole focus will be to ensur
Limelight Networks and Ericsson to Accelerate Content Delivery and Edge Cloud Adoption18.10.2018 15:00 | Pressemelding
Limelight Networks (NASDAQ: LLNW) and Ericsson (NASDAQ: ERIC) have signed an agreement to collaborate on content delivery and edge cloud services. As more traffic shifts to the public internet from private networks, the need for high performance networks and distributed infrastructure is required to maintain a high-quality user experience. A key solution to this is edge cloud computing. Providing computing capabilities close to the user or device gives a superior quality of service. For new low latency applications such as IoT, gaming, and virtual reality, robust computing capabilities at the edge of the network are needed. Communications service providers and technology companies will play a pivotal role in scaling the next wave of internet traffic. Ericsson is partnering with service providers globally to build the Ericsson Unified Delivery Network (UDN) Edge Cloud Platform – a web-scale edge delivery network, driving performance benefits and cost efficiencies. Content delivery is th
World Leader in High-End Mobile Security, Kaymera Technologies, to Expand Adaptive Mobile Threat Defense Footprint18.10.2018 13:56 | Pressemelding
Kaymera Technologies, the leader in high-end Mobile Threat Defense solutions, today announced that BGŻ BNP Paribas have chosen the Kaymera’s Adaptive Mobile Threat Defense Platform to help protect personal and business-related mobile data across its employee base and business partners. According to a recent reports survey of IT Security professionals on Bring Your Own Device (BYOD), one in five organizations has suffered a mobile security breach, primarily driven by malware and malicious WiFi. 24% of organizations confirmed their mobile devices have connected to malicious WiFi networks while 48% were unsure if there have been any mobile security incidents. With at least one device in every large organization likely infected with malware, and one-third of executives experiencing network attacks, most enterprises are looking for a strong defense system against mobile threats. “We were looking for solutions to further increase mobility across our organization by boosting our mobile securi
Piraeus Bank Signs Financing Agreement of €40 million with Thomas Cook Hotel Investments18.10.2018 13:18 | Pressemelding
Piraeus Bank signed a financing agreement of €40 million with Thomas Cook Hotel Investments (TCHI), a joint venture between Thomas Cook plc and LMEY Investments AG. Piraeus Bank is the sole financial partner of TCHI in Greece and the financing will be used to invest in local hotel properties. Thomas Cook Hotel Investments was established in March 2018 to support the growth of Thomas Cook’s own-brand hotels in Spain and Greece. The portfolio of TCHI includes owned hotel properties in Rhodes and Crete under the brand of Sunwing. Thomas Cook Group is one of the world’s leading leisure travel groups, with sales of £9 billion in the year ended 30 September 2017, serving over 20 million customers annually. Thomas Cook was the biggest international tour operator in Greece this year, while it served 3 million customers. Funding of tourism, a vital sector for the Greek economy, is a key priority for Piraeus Bank. With a tourism portfolio in excess of €2 billion, the Bank supports tourism busine
StarLeaf Reinforces Its Global Expansion With New Office in Norway18.10.2018 13:00 | Pressemelding
StarLeaf, a leading provider of premium meeting room solutions and video conferencing services, has expanded its global reach with a new office in Oslo, Norway, enabling it to meet increased demand and serve local customers and partners. This announcement is further testament to the company’s fast-paced growth in key markets, which sees StarLeaf systematically increase its global footprint into key regions and countries. “Norway has a prominent history of originating and using video conferencing and collaboration technologies. However, today businesses are looking for next-generation solutions that deliver greater flexibility and scalability, to match their plans for growth and investment,” said Peter Sanevall, StarLeaf Country Manager for the Nordics Countries. “With the opening of our Oslo office, we are well-positioned to address this demand.” StarLeaf provides an end-to-end business collaboration and meeting room solution delivered by the StarLeaf Cloud and its premium hardware sys
Starbucks Evolves Structure in EMEA to Accelerate Long-Term Strategic Growth18.10.2018 12:30 | Pressemelding
Starbucks Coffee Company (NASDAQ: SBUX) today announced our intention to fully license Starbucks operations in France, the Netherlands, Belgium and Luxemburg to its longstanding strategic partner Alsea, S.A.B. de C.V. (BMV: ALSEA), the largest independent chain restaurant operator in Latin America. Under this proposal, which is subject to relevant local laws, and discussions with relevant employee representatives, Alsea will have the rights to operate and develop Starbucks stores in these markets, building on Starbucks regional growth agenda that drives value through strategic licensed relationships. At the same time the company would introduce a new support structure in its head office in London to better serve an increasingly licensed strategy. “We’re very pleased to build on our 16-year history with Alsea, a long-term strategic partner to Starbucks, with the intention to license our business operations in France, the Netherlands, Belgium and Luxemburg,” said John Culver, group presi