VIIV-HEALTHCARE
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191221005008/en/
About Business Wire
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
ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer19.1.2026 08:30:00 CET | Press release
Based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s ENHERTU in combination with pertuzumab significantly improved progression-free survival versus current first-line standard of care in HER2 positive metastatic breast cancer The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU® (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY
Syngenta to Address Global Agricultural Challenges at WEF, Championing AI to Empower Farmers and Create Open Technology Access19.1.2026 08:00:00 CET | Press release
AI and digital tools are unlocking unprecedented opportunities to strengthen farms and secure food security. New IPSOS study reveals technology adoption gap, underscoring urgent need for equitable technology access. Syngenta champions "Agricultural Intelligence" at World Economic Forum, showcasing Cropwise AI solutions that put cutting-edge tools in the hands of all farmers, especially smallholders. As farmers globally grapple with unprecedented economic, geopolitical, and environmental pressures; the agricultural sector faces a continued contraction. An alarming decrease in active farms worldwide and rising financial distress underscore the urgent need for innovation and technology to ensure a resilient food system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260118646017/en/ Jeff Rowe, Syngenta Group CEO "Farmers today are navigating one of the most complex periods in modern agriculture, facing pressures that demand urg
KPMG Enters Strategic Relationship With Uniphore to Build AI Agents Powered by Industry-Specific Small Language Models19.1.2026 07:00:00 CET | Press release
Collaboration uses KPMG’s knowledge in small language models to accelerate delivery of business outcomes to clients across banking, insurance, energy and healthcare Uniphore, the Business AI company, today announced a strategic relationship with KPMG LLP to operationalize AI agents across internal and client-facing workflows, supporting the firm’s continued effort to move from experimental AI pilots to production-grade deployment. As part of the collaboration, KPMG will work with Uniphore to build AI agents using Uniphore’s Business AI Cloud as a platform for agentic AI and fine-tuned small language models (SLMs), supporting clients across regulated industries including banking, insurance, energy and healthcare. Built on a sovereign, composable, and secure architecture, the platform integrates with KPMG’s existing enterprise systems and data environments, meeting governance and compliance requirements essential to regulated industries. This initiative reflects KPMG’s broader effort to
International Chamber of Commerce, Carbon Measures Announce First Group of Global Experts for Carbon Accounting Panel19.1.2026 06:00:00 CET | Press release
Panelists include senior global leaders from business, academia, and civil society. The International Chamber of Commerce (ICC) and Carbon Measures today announced the first cohort of experts selected to serve on the Technical Expert Panel on Carbon Accounting, which will define the principles, scope and real-world applications of a carbon emissions accounting system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260118104674/en/ The panelists are distinguished leaders and experts across industry, science, civil society, and academia – representing diverse disciplines, geographies, and professional backgrounds. The panel will apply their experience across sustainability, technology, public policy, and industrial and financial systems to establish a timely, accurate and verifiable ledger-based carbon emissions accounting system. This system will track product-level emissions across the value chain and support real-world deci
AI-Powered Creator Monetisation Platform, Fanvue, Hits $100m Run Rate and Raises $22m Series A Investment - as Leading Global Creators Rush to Join the Platform19.1.2026 01:01:00 CET | Press release
Fanvue, the AI-powered creator monetisation platform with a $100m-plus run rate, has announced a $22m Series A investment round. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112458975/en/ Joel Morris, Will Monange and Harry Fitzgerald (left to right) Fanvue has bet big on AI-powered tools changing the face of an industry estimated to be worth over $500B by 2030. The platform, which recently crossed $100m annualised revenue, has over 17 million monthly active users, and is home to 250,000 creators who are using Fanvue’s pioneering AI tools to scale their businesses and earn. Instead of competing with legacy platforms, Fanvue is defining a new category, the Creator AI Economy. Fanvue’s belief is that the next generation of creators will accelerate their earnings through utilising technology. And it’s happening in real time. According to Fanvue, just over 93% of creators on the platform used at least one of the platform’s
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