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
Cessna Citation CJ3 Gen3 Achieves First Flight, Advancing Next-Generation Light Jet Toward Certification29.7.2026 19:31:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE:TXT) company, recently achieved a key milestone as the Cessna Citation CJ3 Gen3 prototype aircraft completed its first flight, advancing the next-generation light jet toward certification. With this milestone, all three next-generation Citation light jets — the CJ4 Gen3, CJ3 Gen3 and M2 Gen3 — have entered flight testing, demonstrating continued momentum across the Cessna next-generation light jet portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260729333762/en/ Cessna Citation CJ3 Gen3 achieves first flight, advancing next-generation light jet toward certification. (Photo credit: Textron Aviation) “This achievement continues the forward momentum of the CJ3 Gen3 program and reflects the discipline, innovation and commitment of this team,” said Chris Hearne, senior vice president, Engineering & Programs. “Comprehensive flight testing will now begin for this aircraft with ri
SES Launches Multi-Orbit Satellite Connectivity on LATAM Airbus, Embraer Fleet29.7.2026 18:30:00 EEST | Press release
SES, a leading space solutions company, was selected by LATAM Airlines to provide multi-orbit inflight connectivity service to its growing fleet of Airbus and Embraer aircraft, solidifying SES’s position as the top provider of multi-orbit broadband service in the Americas and around the world. “LATAM’s passengers will soon benefit from reliable, multi-orbit satellite connectivity that will provide the same fast and dependable internet access they enjoy at home no matter where or when they fly. SES’s partnerships with airlines like LATAM highlight how carriers throughout the Americas are leading the way when it comes to the most advanced connectivity. SES is a trusted partner that powers inflight connectivity,” said Mike DeMarco, SES President of Mobility. More than 60 Airbus (A320NEO and A321XLR) and Embraer aircraft (E195-E2) will be equipped with SES services in the coming years. LATAM will be the largest airline in the region to offer service using SES’s new electronically steered a
Carta Rearchitects Private Capital Operations with Plugins for Claude29.7.2026 17:01:00 EEST | Press release
Carta, the connected platform and AI-native ecosystem for private capital, today announces broad availability of its suite of Plugins for Claude following the initial launch in April 2026. With more than 1,500 companies and firms already using the plugins, Carta is changing the way private capital teams — from founders to CFOs — fundamentally operate, bringing fund administration, cap table management, and dealflow analytics directly into the spreadsheets, presentations, and workflows they already use every day. "For the last decade, private capital operation teams have been held back by a hidden tax: the constant, manual handoff of data between disconnected systems," said Henry Ward, Carta CEO. "Carta is eliminating that broken loop entirely by embedding intelligence directly into the tools teams already use. We are not waiting for an AI-native future for private capital — it is running on Carta today." Carta didn't just give Claude a pipe to its data. Carta built its private-capital
VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNova™ Transcatheter Tricuspid Valve Replacement System29.7.2026 16:00:00 EEST | Press release
VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNova™ system. The randomized controlled study will compare TriNova head-to-head with the commercially available Edwards EVOQUE™ TTVR system. The TRIVITA trial (NCT07516444) initiation marks a significant milestone in advancing treatment for tricuspid regurgitation (TR). The prospective, global, multicenter, randomized (1:1) controlled study is designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement. The study will be conducted in the US and Europe with up to 70 sites participating. The first patient was enrolled at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, and tre
Grid Dynamics Accelerates Enterprise AI-Native Transformation With Workforce Certification and GAIN Platforms Rollout29.7.2026 16:00:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a leading provider of technology consulting, platform and product engineering, and AI-driven digital transformation services, today announced significant momentum in the adoption of its enterprise agentic AI solutions. Organizations across retail, financial services, manufacturing, CPG, and logistics industries are increasingly deploying Grid Dynamics’ agentic AI-native platforms and Forward Deployed Engineering (FDE)-led services to accelerate software delivery, improve operational efficiency, and transform business processes at scale. Grid Dynamics is widely recognized for its enterprise AI expertise and delivery capabilities across Fortune 1000 organizations. Grid Dynamics has partnership agreements with Anthropic and OpenAI to accelerate the adoption of these platforms within enterprises. By the end of October 2026, Grid Dynamics plans to have 90% of its engineers trained and certified on these platforms. Built to suppo
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