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
Reply Earns “NVIDIA Physical AI Specialization” for Production-Ready Robotics and Digital Twins19.10.2026 11:00:00 EEST | Press release
Reply [EXM, STAR: REY] is among the first NVIDIA partners in the world to achieve the “Physical AI Specialization” within the NVIDIA Partner Network (NPN), in recognition of its expertise in developing and deploying AI-driven robotics and digital twin solutions for real-world operating environments. The specialization was awarded following a technical assessment covering a customer implementation, solution architecture, certified OpenUSD expertise and Reply’s development roadmap. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019881053/en/ Reply is among the first NVIDIA partners in the world to achieve the “Physical AI Specialization” within the NVIDIA Partner Network (NPN), in recognition of its expertise in developing and deploying AI-driven robotics and digital twin solutions for real-world operating environments. Physical AI is becoming increasingly relevant in manufacturing, warehousing and logistics as companies mo
Sagemcom Unveils Its New-Generation of VSB (Video Soundbox), Now Bringing Home Cinema and Karaoke to Every Living Room, First Deployed by DNA in Finland19.10.2026 11:00:00 EEST | Press release
Sagemcom announces the immediate availability of the new generation of VSB (Video Soundbox). Since its launch, operators around the world have chosen Video Soundbox to offer their customers a 4K set-top box and speakers combined in a single device. Building on this success, Sagemcom introduces its new VSB that takes home entertainment one step further. It is the world’s first set-top box for operators based on Broadcom’s BCM74116 SoC to be deployed. The VSB now offers deeper bass and wider sound spatialization for an even more immersive experience. Thanks to audio designed by Bang & Olufsen and Dolby Atmos, the sound is pure, powerful and multidimensional for all types of content. Dolby Vision brings true colors and sharp pictures. Today, the VSB goes far beyond the traditional TV experience. It can be further enhanced with Wireless Surround Speakers. Available as an option, they extend the sound across the entire room: films and series take on a true cinema dimension, while live sport
EchoMark Launches European Operations and Partner Ecosystem19.10.2026 11:00:00 EEST | Press release
EchoMark, the award winning invisible forensic watermarking company that identifies the source of information leaks, often in minutes, today announced the launch of its European operations. The full EchoMark platform is now available with European Union data residency, giving customers the option to run watermarking, administration, and leak investigations entirely on EU-based infrastructure. EchoMark has also entered into a partnership with Nomios, a leading European cybersecurity services provider, to deliver, deploy, and support the platform across the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909554797/en/ EchoMark is also investing in the wider European insider risk community. The company has joined the Insider Risk Practitioner Alliance (IRPA) as a Secretariat Tier 2 Partner and is a Gold sponsor of the UK Insider Risk Management Collaboration Centre and the Nordic Insider Risk Management Centre of Exce
Incyte to Highlight Key Oncology Data Presentations at the European Society for Medical Oncology (ESMO) Congress 202619.10.2026 01:05:00 EEST | Press release
Incyte (Nasdaq:INCY) today announced that it will present new data from its oncology portfolio during the European Society of Medical Oncology (ESMO) Congress 2026, being held October 23 - 27, 2026, in Madrid. “The data being presented at ESMO further reinforce our confidence in these novel investigational approaches and their potential to improve and prolong the lives of patients with difficult-to-treat gastrointestinal cancers,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “Importantly, these findings not only provide new clinical insights, but they also inform our registrational development programs, including the Phase 3 KRAS G12D and TGFβR2×PD-1 studies already underway.” Details on rapid oral presentations at ESMO include: INCB161734 (KRAS G12D) Safety and Efficacy of Oral KRAS G12D Inhibitor INCB161734 as Monotherapy or in Combination with Cetuximab (Cetux) in Patients (pts) with Advanced/Metastatic Colorectal Cancer (CRC) Session:
DCO Launches Second Edition of Digital Prosperity Awards to Recognize Solutions Building the Digital Future18.10.2026 21:35:00 EEST | Press release
The Digital Cooperation Organization (DCO) launched the second edition of the Digital Prosperity Awards (DPA), opening applications and nominations for eligible public-sector, private-sector and civil-society digital solutions across Member States and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261018682401/en/ DCO Launches Second Edition of Digital Prosperity Awards to Recognize Solutions Building the Digital Future (Photo: AETOSWire) The Awards recognize technology-driven solutions, initiatives and contributions delivering measurable socioeconomic impact, accelerating digital transformation and advancing an inclusive, sustainable and prosperous digital economy. The inaugural edition honored seven winners in February 2025. Ms. Deemah AlYahya, Secretary-General of the DCO, said: “A prosperous digital future is taking shape today through the vision, commitment and creativity of governments, innovators, organization
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