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
Life-Sciences and Healthcare Communications Leaders John “Zeke” Czekanski and Scott Roberts Join Citrus Global Healthcare Communications Group as Managing Partners21.3.2019 17:21:00 EET | Tiedote
Industry leaders John “Zeke” Czekanski and Scott Roberts have joined Citrus Global Healthcare Communications Group as Managing Partners. Zeke will oversee Citrus Scientific while Scott brings his extensive global market access and value experience in guiding Citrus Access. Together they will actively co-manage Citrus Strategy, providing insights enabling clients to innovate with confidence, broaden opportunities, and drive meaningful human-health outcomes forward. “I’m thrilled to be part of the Citrus Group working in partnership with our clients, the medical community, payers, government agencies, and global healthcare stakeholders. We look forward to delivering meaningful scientific insights and market-access solutions,” commented Zeke. Scott added, “There is a critical need in our industry, especially with highly innovative small to mid-size life-science companies, for a transformational agency applying data and analytics along with a holistic approach to the communications continu
Abzena Announces New Fully Integrated Developability and Optimization Service to Improve Lead Selection and De-risk Biologic Cell Line Development21.3.2019 16:44:00 EET | Tiedote
Abzena, the leading biologics target to GMP partner research organisation (PRO), announced its Cambridge UK site has brought together its extensive discovery, immunogenicity assessment, protein engineering, formulation, bioassay and analytical expertise to launch a developability assessment and optimization service to assist customers in selecting and developing the best lead candidate to take forward for manufacture. The new Developability Service reduces the time, risk and cost required to take multiple lead candidates through cell line development and manufacturing. Biologics have potential liabilities for safety, functionality, stability and scalability and when these issues are identified early alternate leads can be selected, liabilities engineered out or measures can be taken to mitigate risk. The Developability Service also enables the selection of drug candidates most aligned with the target product profile by evaluating a range of functionality and specificity readouts. The s
XPRIZE Identifies 10 Future Breakthroughs Required to Protect Our Forests21.3.2019 16:27:00 EET | Tiedote
Today, on the United Nations’ International Day of Forests, XPRIZE is releasing the Future of Forests Impact Roadmap, created in partnership with Kimberly-Clark Corporation. The digital report and its interactive website, based on future foresight techniques, illustrate the breakthroughs required for a healthier forest ecosystem, which might be the basis of future XPRIZE competitions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190321005409/en/ Across the world, forests provide food security and shelter, protect biodiversity and house indigenous populations. While forests cover more than 30 percent of the Earth’s surface, more than 32 million acres of forests are lost due to human activity every year, with research showing that continued mass deforestation and degradation is accelerating climate change. XPRIZE designs and operates global competitions to incentivize the development of technological breakthroughs that accel
Mark Thorne Joins BCW as Global Chief Financial Officer and Chief Operating Officer21.3.2019 16:17:00 EET | Tiedote
BCW (Burson Cohn & Wolfe), a leading global communications agency, announced today that Mark Thorne has been appointed Global Chief Financial Officer and Chief Operating Officer, effective immediately. Thorne will be a strategic partner to BCW Global CEO Donna Imperato in transforming the agency’s financial model to better reflect its wide range of services and offerings. He is based in New York and replaces Pat Przybyski, formerly Global Chief Financial Officer. “Mark is well known for his strong business acumen, deep operational experience and high-level strategic thinking,” said Imperato. “I have known Mark for many years and am thrilled to now call him my partner. He is the right leader to help BCW execute our strategies and grow exponentially.” Thorne spent the past 20 plus years with Hill+Knowlton Strategies in a range of leadership roles, most recently serving as Global Chief Financial Officer and Global Chief Operating Officer. Prior to that, Thorne was Executive Vice President
Imago BioSciences Announces $40 Million Series B Financing Led by Omega Funds21.3.2019 16:09:00 EET | Tiedote
Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, today announced a $40 million Series B financing led by Omega Funds, a leading international investment firm that creates and invests in life sciences companies. Other investors participating in the round include existing investors Frazier Healthcare Partners, Amgen Ventures, and MRL Ventures Fund as well as HighLight Capital, Pharmaron and Greenspring Associates. Dr. Dina Chaya from Omega Funds will join the board of directors and Dennis Henner will remain Chairman of the Board, representing his fund. “Imago BioSciences is extremely gratified with the interest and support of the investment community; we are particularly pleased with the composition of this new investment syndicate,” said Hugh Young Rienhoff, Jr. M.D., CEO at Imago BioSciences. “These funds will enable Imago to advance our programs through the completion of Phase 2b studies.” “We are excited to work wi
Workiva Wins DevOps Excellence Award in London21.3.2019 16:03:00 EET | Tiedote
Workiva (NYSE:WK), the leading cloud provider of connected data, reporting and compliance solutions, today announced that its Wdesk platform was named the Best Software-Defined Product, last night at Computing's DevOps Excellence Awards dinner. The Computing DevOps Excellence Awards recognize outstanding achievement from organisations, personalities and solutions operating within the DevOps industry. Winners were selected on their superior functionality, level of ability to modernize business processes, positive customer feedback and a strong return on investment. “We are proud to win this prestigious award,” said Marty Vanderploeg, CEO of Workiva. “As the global leader in connected reporting, XBRL and Inline XBRL, our Wdesk platform helps customers all over the world consolidate, connect and tag their data in a single, cloud environment so they are able to reduce risk and save time when filing reports with various regulators and other stakeholders.” XBRL (eXtensible Business Reporting
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