European Commission Grants Marketing Authorization for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the European Commission has granted Marketing Authorization for Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF), a guidelines-recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone. Today’s decision makes BIC/FTC/TAF Gilead’s third FTC/TAF-based STR approved in the European Union in the past three years.
In Europe, BIC/FTC/TAF is indicated as a complete regimen for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. No dosage adjustment of BIC/FTC/TAF is required in patients with estimated creatinine clearance (CrCL) greater than or equal to 30 mL per minute. BIC/FTC/TAF has convenient dosing, does not require testing for HLA-B 5701, and has no food intake or baseline viral load or CD4 count restrictions.
“To help support the long-term health of people living with HIV, it is crucial to have regimens that deliver durable viral suppression with a high barrier to resistance,” said Professor Alan Winston, Professor of HIV and Genitourinary Medicine at Imperial College and Consultant Physician at St. Mary’s Hospital, London, UK. “In clinical trials through 48 weeks, BIC/FTC/TAF has shown high efficacy and zero resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation, and follow-up over time.”
Today’s decision 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 at 48 weeks in all four studies.
Through 48 weeks, no participants in any of the four studies failed BIC/FTC/TAF with treatment-emergent virologic resistance, no participants discontinued BIC/FTC/TAF due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking BIC/FTC/TAF were diarrhea, nausea and headache.
“We are pleased to offer BIC/FTC/TAF, the latest innovation in our comprehensive HIV research and development program, which encompasses prevention, treatment and cure,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. “The approval of BIC/FTC/TAF demonstrates our continued commitment to improving care for people living with HIV, and we look forward to working with health authorities across Europe to ensure that BIC/FTC/TAF is made widely available as soon as possible.”
Additional studies not included in the marketing authorization application are also ongoing, including dedicated studies in women, and in adolescents and children.
BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018.
About Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. 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 12 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 physicians may not see the benefits of prescribing BIC/FTC/TAF for the treatment of HIV-1 infection and the possibility of unfavorable results from additional clinical trials involving BIC/FTC/TAF. 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 March 31, 2018, 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 Biktarvy and Descovy are available from the EMA website at www.ema.europa.eu .
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, +1 650-524-7792
Ryan McKeel, +1 650-377-3548
Stephen Head, +44 (0)7768 705945
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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Iberdrola Recognized as United Nations Global Compact LEAD25.9.2018 00:12 | Tiedote
Today, Iberdrola, one of the world’s largest utilities and the leading renewable energy producer, is pleased to announce that the Company has been recognized as Global Compact LEAD for demonstrating its ongoing commitment to the United Nations Global Compact and its Ten Principles for responsible business. Announced at UN Headquarters in New York during the UN Global Compact Leaders Summit 2018, Iberdrola was identified as being among the highest-engaged participants of the world’s largest corporate sustainability initiative. Lise Kingo, CEO and Executive Director of the UN Global Compact, said, “LEAD companies represent the highest level of engagement with the UN Global Compact. Achieving the Sustainable Development Goals and creating the world we want will not happen without bold action from the responsible business community. We need companies of all sizes — like the ones recognized today — to improve their performance, no matter where they are on their sustainability journey.” “Sin
Pre-Registration for MapleStory 2 Starts Today24.9.2018 20:00 | Tiedote
Pre-registration for MapleStory 2, the newest MMORPG adventure in Maple World, is available starting today. From September 24 through October 8, players can sign-up on the MapleStory 2 Pre-Registration site available here and earn exclusive rewards! Pre-registration web rewards will include unique in-game items such as the Roosting Seagull, Rustic Mushcabin Name Tag, and the Dusty Rickshaw. From September 24 through October 8, players can also receive a Mint Body Pillow by retweeting the new Runeblade trailer on Twitter and/or liking on Facebook. In addition to pre-registration, players who purchased a Founder’s Pack can jump into Head Start starting October 1, which will allow them to join MapleStory 2 's vibrant and immersive world ahead of global launch on October 10. Along with beta improvements, Head Start (October 1 - October 10) will include: Character progression that carries over to the official launch 6 character slots Founder’s Pack items Access to Gemstones Lv. 1 - 50 Quest
First Engineering Faculty in Canada Named after a Woman: Business Leader Gina Cody Makes Historic $15 Million Donation to Montreal’s Concordia University24.9.2018 18:15 | Tiedote
Three decades after becoming the first woman to earn a PhD in building engineering from Concordia University, Gina Parvaneh Cody, MEng 81, PhD 89, has made history by giving $15 million to her alma mater. In recognition of her transformative gift to the “Campaign for Concordia: Next-Gen. Now”, the university has named its faculty of engineering and computer science after the alumna. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005425/en/ (Photo: Business Wire) The Gina Cody School of Engineering and Computer Science is the first engineering faculty in Canada — and one of the first internationally — to be named after a woman. Gina Cody, a top business leader and building engineer, credits much of her success to Concordia because the university provided her with an entrance scholarship. “I arrived in Canada as a young student from Iran in 1979 with $2,000,” she says. “Concordia welcomed me and provided me with support
Dole’s Standard Fruit Celebrates 20-Year Milestone as Environmental Leader24.9.2018 18:00 | Tiedote
Earlier in September Dole Food Company participated in a celebration of the twentieth anniversary of the company’s initial receipt of its ISO 14001 Certification. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005079/en/ Dole Fresh Fruit President Renato Acuña speaks at the anniversary celebration of Dole's landmark environmental sustainability certification. (Photo: Business Wire) On July 2, 1998, Standard Fruit Company of Costa Rica S.A., a subsidiary of Dole Food Company, Inc., became the first agricultural and banana company in the world to receive the globally recognized ISO 14001 Certification for its environmental management policy and the establishment of its Integrated Management System. With the certification, the company further strengthened its robust Environmental Management System, with results that place it at the forefront in the sustainable production of bananas and pineapples. The celebration event, h
Helsinki Joins New York in Commitment to Review Local Progress Toward Global Sustainable Development Goals24.9.2018 17:42 | Tiedote
In July 2018, the City of New York became the first city in the world to submit to the United Nations its progress toward the Sustainable Development Goals (SDG’s) on city level. As the first European city Helsinki will follow New York City and become the second city in the world in effort to showcase crucial role of cities in achieving UN agenda for people, prosperity and planet. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005633/en/ As the first European city Helsinki will follow New York City and become the second city in the world in effort to showcase crucial role of cities in achieving UN agenda for people, prosperity and planet. Photo: Jussi Hellsten The Mayor of Helsinki Jan Vapaavuori announced Helsinki’s commitment to the voluntary local review at a panel conversation with New York City’s Commissioner of International Affairs Penny Abeywardena at the Social Good Summit in New York City on Sunday. Even thou
ARTMS’ QUANTM Irradiation System™ to Be Featured at Two International Conferences in September24.9.2018 16:00 | Tiedote
ARTMS Products, Inc. announced today that it has been invited to present at the National Nuclear Security Administration’s 2018 Mo-99 Topical Meeting on Tuesday, September 25th and the Third International Symposium on Technetium and other Radiometals in Chemistry and Medicine on Thursday, September 27th. Joel Kumlin will present at the 2018 Mo-99 Topical Meeting in Knoxville, TN, during Session 7, Production Projects and Technologies II, at 13:00EDT on September 25th. Mr. Kumlin will be discussing progress on implementation of the ARTMS QUANTM Irradiation System™ for producing technetium-99m. The QIS™ combines local production control and a cost-effective, easy-to-use solid target system for the production of Tc-99m on most cyclotron systems. ARTMS recently announced that the QIS™ received CE mark approval and has been installed in a number of countries throughout the world. ARTMS also announced that Dr. Paul Schaffer, CTO, has been invited to present at the Third International Symposi
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