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 and IEO Launch Collaboration to Co-Develop and Train Domain-Specific Large Language Models for Oncology4.6.2026 11:10:00 EEST | Press release
Reply [EXM, STAR: REY] and the European Institute of Oncology (IEO) have launched a collaboration focused on the co-development and training of domain-specific Large Language Models for oncology. The initiative brings together Reply’s expertise in building frontier generative models grounded in enterprise knowledge with the IEO’s clinical expertise and data assets to develop models tailored to highly complex oncology settings. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604488955/en/ Reply and the European Institute of Oncology (IEO) have launched a collaboration focused on the co-development and training of domain-specific Large Language Models for oncology. As a first step, the IEO’s clinical teams and Information Systems department are working with a multidisciplinary Reply team with deep expertise in healthcare and LLM specialisation to define and prioritise the use cases that will guide development, while also map
Corona Launches 2026 Beach 100 Guide, Invites The World To Explore The Outdoors This Summer4.6.2026 11:00:00 EEST | Press release
Corona, the world’s most valuable beer brand1, today announced the return of its annual global beach guide, the 2026 Corona Beach 100, ahead of World Oceans Day on June 8. The highly anticipated second edition spotlights 100 breathtaking and varied ocean-front destinations around the world while celebrating the natural ecosystems and local communities that help bring them to life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604412899/en/ 2026 Corona Beach 100 - Legzira Beach, Morocco Connected to Corona’s “This Is Living” platform, which invites consumers to step outside and live life to the fullest this summer, the 2026 guide features 27 new beaches, hundreds of localized Tripadvisor travel experiences inspired by the world’s most breathtaking coastlines, and expanded Beach 100 Grants with Oceanic Global – all inviting people to answer “Living Is Calling” through exploration, connection, and conservation. “Following t
UK AI Minister Kanishka Narayan Joins The AI Summit London as 10th Anniversary Agenda Expands Across Enterprise AI, Innovation and Policy4.6.2026 11:00:00 EEST | Press release
The AI Summit London today revealed the full agenda for its highly anticipated 10th anniversary edition, delivering its most expansive and future-focused programme to date. Taking place 10–11 June at Tobacco Dock as the headline AI event of London Tech Week 2026, the Summit expects more than 5,000 attendees, 300 speakers, 100+ sponsors and exhibitors, and a special executive presentation from Kanishka Narayan, Minister for AI and Online Safety, Department for Science, Innovation and Technology, across two days dedicated to the commercial realities and transformative potential of artificial intelligence. The 10th anniversary has been designed to move the conversation beyond experimentation and into enterprise-wide execution. New in 2026, the programme introduces The AI Impact Arena, delivering focused briefings and live demos, and The Start-Up & Investor Village, featuring innovative founder content and rising AI stars. Rounding out the attendee experience will be refreshed conference t
Lantern Expands Its Platform for Solving the Data Trust Problem with Strategic Acquisition and Key Executive Hires4.6.2026 11:00:00 EEST | Press release
Lantern Limited (“Lantern”), the data assurance platform for private markets, announced today a strategic acquisition, expanded platform capabilities, and key leadership additions to address one of private markets biggest operational challenges: transforming fragmented, disconnected data across multiple sources into trusted, actionable intelligence. Private markets run on data, yet much of that data remains siloed, trapped in PDFs, and processed through highly manual workflows across both fund managers and investors. While GPs have increasingly modernized how they manage and report fund information internally, LPs still spend billions of dollars each year manually extracting, normalizing, and reconciling data from capital notices, quarterly statements, and other fund documents. With the acquisition of Freyda Limited (“Freyda”), one of the leading AI document intelligence platforms for institutional Limited Partners and fund administrators, Lantern now delivers an end-to-end solution fo
KAYTUS Launches MotusAI Enterprise Token Management Platform4.6.2026 10:02:00 EEST | Press release
KAYTUS, a leading provider of AI infrastructure and liquid cooling solutions, today announced the launch of enterprise-grade token management capabilities within MotusAI, enabling organizations to rapidly build, deploy, and operate secure on-premises AI token platform. This pioneering infrastructure enhancement transforms traditional GPU hardware into a unified, governable, and highly efficient internal token service ecosystem. By enabling rapid private deployment, MotusAI provides enterprises with a cost-competitive foundation for accelerating the scale-up of enterprise-grade AI agents while ensuring strong data privacy. Why Enterprises Must Build a Private Token Management Platform Now? As enterprise AI evolves from isolated model-based tools to interconnected AI agent systems that enable deep workflow automation, tokens are emerging as the fundamental “computing currency” of the modern organization. While standard LLM queries typically involve predictable, one-off inference requests
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