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
LR Health & Beauty Strengthens Its Management Team With Martin Lipp as New Chief Financial Officer (CFO)7.9.2026 16:36:00 EEST | Press release
The LR Health & Beauty GmbH, Europe’s leading social commerce company for high-quality nutritional supplements and beauty products, is strengthening its management team: effective 7 September 2026, Martin Lipp takes over as Chief Financial Officer (CFO) and joins the Executive Management Team. In his new role, Martin Lipp will be responsible for Global Controlling & Finance, Legal, IT and Operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907262360/en/ Martin Lipp, new CFO of the LR Group “With Martin Lipp, we are gaining a highly experienced international finance executive with extensive expertise in managing and transforming businesses. During the current transition phase, he will enrich the senior management in particular with his strong transformation expertise and excellent know-how in the areas of finance, operations and IT. Together, we will consistently drive forward the implementation of our strategy with
Capcom’s Onimusha: Way of the Sword Sells Over 1 Million Units on Launch Day!7.9.2026 16:00:00 EEST | Press release
Capcom Co., Ltd. (TOKYO:9697) today announced that worldwide sales of Onimusha: Way of the Sword, the latest title in the series, have surpassed 1 million units on the first day of its release. Driven by the performance of this title, cumulative sales of the Onimusha series have now surpassed 10 million units. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907554827/en/ Onimusha: Way of the Sword key art Onimusha: Way of the Sword, which marks the first new title in the series in over 20 years, is a swordplay action game featuring protagonist Miyamoto Musashi that is set in Edo-era Kyoto. This title enhances the exhilarating sword-based action of the series with cutting-edge technology while also providing a compelling story and beautiful visual depictions. In addition, through several marketing initiatives prior to launch, such as multiple demo releases and hands-on exhibitions, Capcom worked to expand awareness among a
A2RL Sets New International Benchmark with Europe’s First Five-Car Autonomous Race7.9.2026 15:16:00 EEST | Press release
The Abu Dhabi Autonomous Racing League (A2RL) completed the first-ever multi-car autonomous race in Europe at the Imola Circuit in Italy on 5 September 2026, as part of ACI Racing Weekend. Kinetiz (UAE) won the League’s inaugural international race, across 12 laps of one of the most technically demanding circuits in world motorsport. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907943650/en/ A2RL Sets New International Benchmark with Europe’s First Five-Car Autonomous Race (Photo: AETOSWire) Organised by ASPIRE, the grand challenges arm of Abu Dhabi’s Advanced Technology Research Council (ATRC), A2RL brings together key players across Abu Dhabi’s autonomous mobility ecosystem, with strategic oversight from the Smart and Autonomous Systems Council (SASC). A2RL has evolved from a public testbed for AI under extreme race conditions into a competitive racing series. Imola marked the League’s first international chapter foll
Dubai Chambers to Train 14,000 Private Sector Companies in Agentic AI7.9.2026 13:15:00 EEST | Press release
Dubai Chambers has launched specialised Agentic AI training for more than 14,000 private sector companies, helping businesses build the skills needed to adopt the technology across their operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907193930/en/ H.E. Eng. Sultan bin Saeed Al Mansoori speaking during the launch of the training programme (Photo: AETOSWire) The training forms part of Dubai’s wider programme to transition the private sector towards Agentic AI, launched under the directives of H.H. Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister and Minister of Defence of the UAE, and Chairman of The Executive Council of Dubai. Delivered through the new Dubai Chambers Academy, an integrated e-learning platform, the training provides practical guidance on applying Agentic AI in business. Participants will explore tools and solutions that can improve operations, effici
REPLY: A Face Only A Mother Could Love by Robert Gaudette Wins the Reply AI Film Festival 2026, the International Competition Exploring the Intersection of Cinema and Artificial Intelligence7.9.2026 13:02:00 EEST | Press release
Canadian filmmaker Robert Gaudette, with his short film A Face Only A Mother Could Love, has won the Reply AI Film Festival 2026, the international competition created by Reply to explore new frontiers in cinematic language through the use of artificial intelligence. The award was presented on Sunday 6 September in Venice, during a ceremony organised by Reply and Mastercard at the Match Point Arena, set up at Tennis Club Venezia on the Lido, alongside the 83rd Venice International Film Festival. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907478421/en/ Canadian filmmaker Robert Gaudette, with his short film A Face Only A Mother Could Love, has won the Reply AI Film Festival 2026, the international competition created by Reply to explore new frontiers in cinematic language through the use of artificial intelligence. Now in its third edition, the Reply AI Film Festival received more than 3,000 short films from 76 countri
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