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
The Global Photonics Community Converges in San Francisco as More Than 23,000 Register for Photonics West 20263.2.2026 23:14:00 EET | Press release
SPIE, the international society for optics and photonics, brought the global optics and photonics community to San Francisco, California, for another successful and enlivening Photonics West. With more than 23,000 registrants, the annual conference and exhibition connected attendees from 40 countries, showcasing the transnational and collaborative spirit of the interdisciplinary industry. The dynamic event ran from 17 to 22 January, with 4,200 technical presentations across 100 conferences, 4 stages of industry-focused panels and presentations, 49 courses, and approximately 1,600 exhibitors in the five expos: Photonics West, BiOS, Quantum West, AR | VR | MR, plus, in its inaugural year, Vision Tech. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203925940/en/ Attendees of the 2026 SPIE Photonics West fill the Moscone Center, where nearly 1,600 exhibitors showcased their products. With an emphasis on the application of adv
Vena To Acquire Acterys, Creating a New Category of Enterprise Performance Management: Orchestrated Planning3.2.2026 18:00:00 EET | Press release
Vena, the only complete FP&A platform powered by agentic AI and purpose-built to amplify the Microsoft technology ecosystem, today announced it has entered into a definitive agreement to acquire Managility Pty Ltd, operating as Acterys (“Acterys”), the industry’s leading Power BI–based operational planning and app development platform, subject to customary closing conditions and regulatory approval. This acquisition unlocks a category-defining way for enterprises to combine planning, analytics, and application development within the Microsoft tools they already trust to run their business. By combining Vena’s Excel-native financial planning and analysis (FP&A) capabilities with Acterys’ proprietary Power BI write-back engine and unified analytics within Microsoft Fabric, Vena is creating the first Microsoft-native environment for Orchestrated Planning, an operating model that moves organizations beyond integrated planning into fully orchestrated and agentic AI-powered execution. Orches
Volante Technologies named a Leader in Gartner® Magic Quadrant™ for Banking Payment Hub Platforms3.2.2026 17:15:00 EET | Press release
Volante Technologies, the global leader in Payments as a Service (PaaS), today announced its recognition as a Leader in the 2026 Gartner® Magic Quadrant™ for Banking Payment Hub Platforms, which evaluates vendors based on Ability to Execute and Completeness of Vision. In Volante’s view, Gartner positioned them as a Leader based on their capacity to support enterprise-scale payment processing in banks and financial institutions across multiple regions, deployment models, and operational environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203149834/en/ This graphic was published by Gartner, Inc. as part of a larger research document and should be evaluated in the context of the entire document. As the highest positioned provider in Ability to Execute, Volante believes its AI-poweredPayments Platform is ISO 20022 native and provides complete, always-on, and composable payment processing support and can be deployed p
Toptal Ranked #1 Most Reliable Professional Services Company in America by Newsweek3.2.2026 17:00:00 EET | Press release
Toptal, the world’s largest fully remote workforce, has been ranked the #1 most reliable professional services company in America on the America’s Most Reliable Companies 2026 list by Newsweek and Statista. The list ranks top US companies based on trust, dependability, and consistent performance in their industry. In Newsweek’s ranking of 300 companies across all industries, Toptal took 10th place, right behind Bank of America and Oracle, which tied for 9th. As the most reliable professional services organization in America, Toptal, which ranked 11th in absolute rankings across all companies, placed well ahead of companies like Accenture (33), Deloitte (39), and Cognizant (66). The America’s Most Reliable Companies 2026 ranking is based on an independent survey of more than 80,000 evaluations submitted by 2,400 business decision-makers at America’s largest companies, including Apple, Dropbox, Johnson & Johnson, and UPS, making this recognition an especially meaningful indicator of prod
HTEC Research Reveals the Real AI Scaling Challenge: It’s Not the Technology3.2.2026 16:46:00 EET | Press release
AI has moved from ambition to action. Every organization is deploying it. Yet for most enterprises, the real challenge is only just beginning. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203951136/en/ HTEC, a global AI‑first provider of software and hardware design and engineering services, released Executive Summary: A Cross‑Industry View of the State of AI in 2025, a global research report capturing how senior executives are navigating the next phase of AI transformation—and why scaling value remains elusive. Today, HTEC, a global AI‑first provider of software and hardware design and engineering services, released Executive Summary: A Cross‑Industry View of the State of AI in 2025, a global research report that captures how senior executives are navigating the next phase of AI transformation—and why scaling value remains elusive. Based on insights from 1,529 C‑suite executives worldwide, the research offers one of th
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