ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
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
GigaDevice Highlights Breakthroughs Across AI, Power, and Consumer Applications at Embedded World 20253.11.2025 18:00:00 EET | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, will present its latest breakthroughs in AI-driven facial and voice recognition, power management, and consumer applications, at this year’s Embedded World North America. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251103394601/en/ This is the second running of EWNA, with the expo taking place in Anaheim, CA, from the 4th of November. GigaDevice’s technology will be on display at Booth #6085 throughout the three-day exhibition. Like its European sister show, the event brings together many of the leading developers and system architects from across the embedded electronics sector. GigaDevice's demonstrations will highlight the performance and versatility of its GD32 MCU family across several demanding applications: Edge AI Recognition Systems: GigaDevice will showcase facial and voice reco
Coulson Aviation Develops SafeFuel, the First Onboard Fuel Quality Assurance and Protection System3.11.2025 17:30:00 EET | Press release
Coulson Aviation (USA), the world’s largest aerial firefighting company and operator of the most advanced mixed fixed- and rotary-wing firefighting fleet, has developed SafeFuel, the aviation industry’s first onboard system designed to verify fuel quality and detect contamination during refueling. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251103342390/en/ Coulson SafeFuel is the world’s first patented onboard fuel-quality assurance and protection system. It continuously analyzes the product during refueling, detecting contamination or chemical degradation in real-time, preventing unsafe fuel from ever reaching the tanks. The innovation comes amid growing safety concerns following multiple fuel-related incidents in military and commercial aviation, and recent Navy aircraft accidents under investigation. Coulson Aviation’s aircraft often operate in remote environments around the world, where the risk of contaminated or of
Stefanini Group and Scopism Survey Reveals Rapid AI Adoption, Identifies Key Global Trends Shaping Service Integration and Management (SIAM)3.11.2025 16:42:00 EET | Press release
Stefanini Group, a global tech consulting company with strong expertise in digital transformation and artificial intelligence solutions, and Scopism, a global leader in Service Integration and Management (SIAM) best practices, today announced the release of the Global SIAM Survey 2025 White Paper. The eighth annual report, sponsored by Stefanini, was launched and presented by a panel at the Scopism Service North Conference in Manchester, UK, and provides unrivalled insights into SIAM adoption, maturity, and emerging trends worldwide. The survey continues to track the impact of artificial intelligence (AI) on SIAM models. Results show that while reported use of AI in SIAM models overall has remained stable, AI adoption within specific areas, such as incident management, has increased significantly, with 85% of organizations now reporting AI use. At the same time, respondents noted that challenges around integration (74% of respondents), cost (64%) and data privacy (50%) remain major con
Incyte Announces More than 50 Abstracts Accepted for Presentation at the 2025 ASH Annual Meeting3.11.2025 16:31:00 EET | Press release
Incyte (Nasdaq:INCY) today announced that data from key programs in its oncology portfolio will be presented in both oral and poster sessions at the 2025 American Society of Hematology (ASH) Annual Meeting, to be held December 6 – 9, 2025, in Orlando. "This year’s Incyte presentations highlight the potential of our portfolio to transform the treatment of blood cancers, specifically for patients with myeloproliferative neoplasms (MPNs),” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "New data for our first-in-class mutCALR-targeted monoclonal antibody, INCA033989, as a monotherapy in patients with myelofibrosis (MF) who are intolerant or refractory to ruxolitinib, and in combination with ruxolitinib in patients with MF who experience a suboptimal response to ruxolitinib monotherapy will be highlighted as an oral presentation. Updated data for INCA033989 in essential thrombocythemia (ET) will also be presented. Additionally, we look forward to shari
Saudi Arabia Issues Green, Social, and Sustainable Debt Instruments Guidelines to Support ESG Investment and Align with Global Standards3.11.2025 16:18:00 EET | Press release
The Capital Market Authority (CMA) of Saudi Arabia has issued the Guidelines for Issuing Green, Social, Sustainability, and Sustainability-Linked Debt Instruments, marking a strategic milestone in the Kingdom’s journey to build a diversified and globally integrated capital market under Vision 2030. Effective from May 27, 2025, the Guidelines provide issuers with a framework aligned with international standards. This initiative is part of CMA’s 2024–2026 Strategic Plan and reflects the Kingdom’s ongoing commitment to advancing ESG-aligned capital formation, enhancing transparency, and expanding financing channels across the public and private sectors. Abdullah Al-Moqbel, Director of the Sustainability Department at the CMA, said: “This framework supports the growth of Saudi Arabia’s sustainable finance market. It enables issuers to meet global investors' expectations, enhance investor confidence, and support the Kingdom’s position as a regional center for sustainable finance, in line wi
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