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
SES and Air Astana Introduce Multi-orbit Inflight Connectivity on A321LR Fleet30.10.2026 19:35:00 EET | Press release
SES was selected by Air Astana, the award-winning flag carrier of Kazakhstan, to introduce next-generation inflight connectivity services across its Airbus A321LR fleet. The first connected aircraft entered commercial service on 29 October 2026. Fleet-wide deployment will continue across the remaining A321LR fleet. Equipped with SES’s new electronically steered array (ESA) antenna, the aircraft delivers reliable connectivity over the SES multi-orbit network. SES will provide a fully managed inflight connectivity service across the fleet, enabling Air Astana passengers to enjoy a seamless online experience throughout their journey. “Airlines are increasingly looking for connectivity solutions that deliver a seamless passenger experience while providing the flexibility to evolve with changing customer expectations,” said Blane Boynton, Senior Vice President, Aviation at SES. “SES's multi-orbit solution will enable Air Astana to offer a consistent, high-quality online experience across it
CIRCOR to Expand Industrial Portfolio with Acquisition of Green Silence Group S.p.A.30.10.2026 18:06:00 EET | Press release
CIRCOR, a KKR portfolio company and global manufacturer of flow control products for industrial and naval markets, today announced that it has signed a definitive agreement to acquire Green Silence Group S.p.A., an Italian provider of hydraulic pumps, electric motors and advanced engineering solutions. The acquisition will bring together the complementary capabilities of Settima, Motive and Spin expanding CIRCOR’s Industrial portfolio with three-screw and ultra-low-noise hydraulic pumps, Motive electric motors, high-efficiency rare-earth-free motor technologies, power electronics and advanced engineering capabilities. Together, these technologies will broaden CIRCOR’s ability to deliver integrated solutions that improve system efficiency, reduce energy consumption and critical raw materials dependency, and address evolving customer needs across industrial and mobile applications. The combination will also provide Green Silence Group access to CIRCOR’s global commercial and operational
Quectel Sues Telit, Alleging False Statements, Cybersquatting and Unfair Competition30.10.2026 17:41:00 EET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced that it has filed legal action in the United States District Court for the Southern District of Florida against Telit IoT Solutions Inc. The lawsuit seeks to bring an end to Telit’s campaign of false and misleading claims about Quectel and its products. Quectel alleges that, rather than competing on the strength of its products and technology, Telit engaged in a coordinated campaign to undermine Quectel’s reputation by exploiting geopolitical concerns surrounding Chinese technology companies. According to the complaint, Telit funded, promoted, and amplified false and misleading claims about Quectel’s products while positioning itself to customers as a safer “Western” alternative. The lawsuit further alleges that Telit engaged in cybersquatting involving Quectel’s U.S. domain name to advance its campaign. Quectel maintains that these alleged actions have caused substantial harm to its sales, customer
TestMu AI Launches Kane CLI Exploration, an AI Agent That Maps an Entire Web App From a Single URL and Turns It Into Tests30.10.2026 16:00:00 EET | Press release
TestMu AI, the Full Stack Agentic AI Quality Engineering platform, announced Kane CLI Exploration, an autonomous agent that learns a web application before anyone writes a test. Given a single URL, it walks the entire app on its own, flags problems along the way and gives Kane CLI the context it needs to generate and run tests, even when no requirements, user stories or acceptance criteria exist. Every test plan starts from something written down, and many apps never had it. Legacy products lose their specs when the people who wrote them move on, and apps a coding agent built in a week often have no record of intended behavior beyond the prompt history. With nothing to test against, a testing agent ends up grading the app against itself. Starting from the URL a developer provides, the exploration agent moves through every page, junction and flow it can reach, the way a new QA engineer clicks through a product in their first week. For each page it records the controls, the flows in and
The Estée Lauder Companies and Microsoft Announce a New Strategic Partnership to Power Enterprise Efficiency and Consumer-Centric Growth30.10.2026 15:22:00 EET | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced a new strategic partnership with Microsoft Corp. to advance its cloud and data foundation and support the responsible adoption of AI-enabled capabilities across the enterprise. The collaboration will help connect data and intelligent tools to support faster innovation, more efficient operations, and more relevant consumer experiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030616823/en/ This new partnership is a critical part of The Estée Lauder Companies’ One Operating Ecosystem, which brings together shared platforms, connected data, and best-in-class partners to enable consistent, scalable, and effective execution across the enterprise. A key initiative of this expanded partnership is harnessing the Microsoft platform to advance the company’s Unified Data Platform. This foundation is the core enabler for AI and agility—connecting the company's data acro
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