ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
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
BitGo Secures OCC Approval to Convert to Federally Chartered National Trust Bank13.12.2025 03:10:00 EET | Press release
BitGo Holdings, Inc. (“BitGo”), the digital asset infrastructure company, today announced that the Office of the Comptroller of the Currency (“OCC”) approved its application to convert BitGo Trust Company, Inc., a South Dakota-chartered trust company, to a national bank named BitGo Bank & Trust, National Association (N.A.). With today’s OCC approval of its conversion, BitGo’s Trust Company subsidiary is now operating as BitGo Bank & Trust, National Association (N.A.). BitGo Bank & Trust, N.A. will operate under a single, uniform federal supervisory regime, enabling it to deliver the clarity, governance, and regulatory certainty institutions expect from a federally regulated fiduciary. This approval reinforces BitGo’s position as an institutional foundation for the modern financial system, combining bank-level oversight with the security, compliance, and scalability that define BitGo’s infrastructure. Under the national bank charter, and subject to applicable law and OCC requirements, B
FIA, Formula 1 Group and All 11 Race Teams Officially Sign the Ninth Concorde Agreement, Securing Strength and Stability for the Sport in Pivotal Five-Year Agreement12.12.2025 18:10:00 EET | Press release
The Fédération Internationale de l'Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, and Formula 1 Group, the Commercial Rights Holder, have today announced the signing of the Concorde Governance Agreement, a crucial contract defining the regulatory framework and governance terms of the FIA Formula One World Championship until 2030. This follows the announcement in March that the 2026 Commercial Concorde Agreement had been signed by all the teams and Formula 1 Group. Together, these agreements constitute the ninth Concorde Agreement, representing a major step forward in the professionalisation and global development of the sport. First introduced in 1981, the Concorde Agreements are designed to promote sporting fairness, technological innovation and operational excellence, and align all key stakeholders around a shared vision for structured governance and continued growth of the sport. Each iteration of the Concorde Agr
Anabranch Capital Management, LP supports relisting of SmartCraft ASA to Nasdaq Stockholm12.12.2025 17:26:00 EET | Press release
Reference is made to the stock exchange announcement by SmartCraft ASA ("SmartCraft" or the "Company") on 1 December 2025 regarding the contemplated relisting of SmartCraft from Euronext Oslo Børs to Nasdaq Stockholm (the "Relisting") and the announcement of a cross-border merger to effect the Relisting. Funds managed by Anabranch Capital Management, LP (“Anabranch”) intend to vote in favour of the merger plan resolved by the boards of SmartCraft and its Swedish wholly owned subsidiary, SmartCraft Group AB (publ), to effect the Relisting at the Company's extraordinary general meeting planned for January 2025 (the "EGM"). Anabranch intends to vote with all Anabranch shares held at the Record Date for the EGM in favour of the relisting effected by the merger plan. Funds managed by Anabranch currently hold approximately 15.9 million shares in SmartCraft. Disclaimer: The views expressed are those of the authors and Anabranch Capital Management, LP as of the date referenced and are subject
Mohammed Ben Sulayem Re-Elected as President of the FIA12.12.2025 16:49:00 EET | Press release
The Fédération Internationale de l’Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, today confirms that Mohammed Ben Sulayem has been re-elected as President of the FIA, following the election of his Presidential List by the General Assembly in Tashkent, Republic of Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212213181/en/ President Mohammed Ben Sulayem now begins his second four-year term, having overseen a period of significant renewal and stabilisation for the organisation since his initial election in 2021. Over the past four years, the FIA has undergone a wide-ranging transformation, improving governance, operations and restoring the financial health of the federation. These changes have strengthened the FIA’s position as the world’s governing body for motorsport and the leading authority on safe, sustainable, and affordable mobility.
Capcom’s All-new IP PRAGMATA to Launch on April 24, 2026!12.12.2025 16:00:00 EET | Press release
Capcom Co., Ltd. (TOKYO:9697) today announced that sci-fi action-adventure game PRAGMATA, a completely new IP, is scheduled for release on April 24, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212791950/en/ PRAGMATA Key Art PRAGMATA is a new type of sci-fi action-adventure game mixing puzzle and action elements. In the game, which takes place on the moon in a near-future world, the spacesuit-clad Hugh and android girl Diana cooperate while fighting their way back to Earth. By bringing the title to Nintendo Switch™ 2 in addition to PlayStation®5 system, Xbox Series X|S and PC, Capcom looks to further advance its multi-platform strategy and expand its user base. Moreover, a playable demo of the game will be released first on PC starting today, December 12, to further convey the appeal of the title. The company hopes that players look forward to PRAGMATA, which has already garnered acclaim for its playable demos at
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