ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
21.12.2019 11:46:00 EET | Business Wire | Press release
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.
The reasons given in the CRL relate to Chemistry Manufacturing and Controls (CMC). There have been no reported safety issues related to CMC and there is no change to the safety profile of the products used in clinical trials to date. ViiV Healthcare will work closely with the FDA to determine the appropriate next steps for this New Drug Application.
Cabotegravir is an integrase strand transfer inhibitor developed by ViiV Healthcare and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC. The cabotegravir and rilpivirine long-acting regimen is an investigational product and not approved anywhere in the world.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person responsible for arranging the release of this announcement on behalf of GSK is V.A. Whyte, Company Secretary.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191221005008/en/
Contact information
ViiV Healthcare Media enquiries:
Audrey Abernathy, +1 919 605 4521
Stephen Rea, +44 (0) 78 8126 9009
GSK Global Media enquiries:
Simon Steel, +44 (0) 20 8047 5502
Kathleen Quinn, +1 202 603 5003
Analyst/Investor enquiries:
Sarah Elton-Farr, +44 (0) 20 8047 5194
Danielle Smith, +44 (0) 20 8047 0932
James Dodwell, +44 (0) 20 8047 2406
Jeff McLaughlin, +1 215 751 7002
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
L&T Technology Services, Databricks Partner to Deliver Industrial AI at Scale for Asset-Intensive Industries11.6.2026 13:30:00 EEST | Press release
L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in AI, Digital & ER&D Consulting Services, today announced a strategic go-to-market partnership with Databricks, the leading Data and AI company, to co-develop and deliver Industrial AI solutions that advance Engineering Intelligence (EI) for asset-intensive enterprises. Anchored in LTTS' Sustainability segment, spanning Process Engineering, Discrete Manufacturing and Industrial Products, the partnership will support Energy, Petrochemicals and Industrials clients globally. As industrial organizations seek to unlock greater value from decades of operational and engineering data, the alliance will combine LTTS’ deep domain capabilities with the Databricks platform to transform complex plant data into Engineering Intelligence - enabling improved asset reliability, operational efficiency and sustainability performance. The partnership brings together LTTS’ expertise in forward looking technologies and extensive experience ac
Faire Marks Five Years of Growth Outside North America: Over 100,000 Retailers, 50,000 Brands, and More Than One in Four Brands Now Selling Across Borders11.6.2026 12:05:00 EEST | Press release
Five years after launching outside North America, Faire’s community of more than 100,000 retailers and 50,000 brands across 30+ countries in Europe, Australia, and New Zealand shows a retail sector that is innovating and thriving, well beyond the big cities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611115823/en/ Faire Celebrates 5 Years of Growth in Europe "It has been a phenomenal five years for Faire internationally, and the opportunity ahead has never been clearer,” said Olivier Buffon, VP and Head of International at Faire. “Europe represents a retail market comparable in scale to North America, and the challenges Faire was built to solve exist wherever independent retail exists. A global platform is more valuable for everyone, and we’re so proud to support businesses becoming more confident and more global in how they buy and sell.” A Retailer Network Spanning Tens of Thousands of Towns Independent retail is al
Stallergenes Greer Will Present New Evidence on Long-term Outcomes in Allergen Immunotherapy at EAACI 202611.6.2026 11:09:00 EEST | Press release
Stallergenes Greer, a global leader in allergy care, will present new clinical evidence and scientific advances in allergen immunotherapy (AIT) at the European Academy of Allergy and Clinical Immunology (EAACI) congress, taking place from June 12 to 15 in Istanbul, Turkey. The company will host a scientific symposium entitled “From Nobel Prize discovery to AIT clinical evidence: Shaping pathways to respiratory allergy remission.”Three leading international experts will explore how landmark breakthroughs in immunology have deepened our understanding of immune tolerance, presenting emerging data on remission and long-term outcomes in respiratory allergy. Together, these insights reinforce AIT’s disease-modifying potential and its growing role in personalised medicine. “EAACI 2026 is an exceptional forum for the global allergy community to exchange knowledge and advance the field. Stallergenes Greer is proud contribute to these conversations, bringing together world-leading experts in pur
NIPPON KINZOKU’s “FINE PIPE” Series Welded Drawn Pipes Outperforming Seamless Pipes11.6.2026 11:01:00 EEST | Press release
NIPPON KINZOKU CO., LTD. (TOKYO:5491) (Headquarters: Minato-ku, Tokyo) has commercialized its “FINE PIPE” series *1, -welded drawn pipes that outperform traditional seamless pipes. By leveraging its unique expertise as a material manufacturer and proprietary processing technologies (welding, drawing, and annealing), the company delivers high-quality, eco-friendly, and cost-effective solutions. FINE PIPE is already widely adopted across various sectors, including automotive parts, measuring instruments, and industrial equipment, to meet the most demanding precision requirements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611874307/en/ In response to the growing demand for higher performance and faster processing in analytical and medical devices, NIPPON KINZOKU has developed two innovative products based on its FINE PIPE technology: "High-Precision Inner Surface" small-diameter tubes and "FINE PEEK-ST" stainless steel
Comrade Trustee Services goes live with Smartstream’s Air, the AI reconciliation and data automation solution11.6.2026 10:55:00 EEST | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces that Comrade Trustee Services Limited (CTSL), trustee for the Defence Force Retirement Benefit Fund in Papua New Guinea, has gone live with Smartstream’s Air, the AI reconciliation and data automation solution – cutting processing times from eight hours to under five minutes. The go-live delivers a fully automated, straight-through reconciliation workflow, enabling CTSL to significantly improve operational efficiency, accuracy and auditability. CTSL operates in a complex data environment, reconciling multiple file types, including fixed-length files and PDFs, requiring advanced matching logic. To manage this and scale, CTSL adopted Air for its ability to handle diverse data structures, custom integrations, and ETL-based transformations, delivering high automation and match rates. This has replaced manual data collection and Excel pre-processing, cutting processing
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom