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
JSS: 2025 Sake Exports Grew Steadily, Reaching a Record 81 Markets6.2.2026 05:00:00 EET | Press release
Sake exports continued to expand in 2025 in both value and volume, with export destinations reaching a record 81 countries and regions. Export value increased 6% year on year to 45.9 billion yen, while export volume rose 8% to 33.55 million liters (3.73 million cases on a 9-liter basis), marking the second-highest export performance on record. The average export unit price per 750 ml bottle declined 2% year on year to 1,026 yen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205671686/en/ Sake Export Performance by Country (Top 10, 2025) Export value has nearly doubled since 2020, and the CAGR over the past five years reached 14%. This underscores sake’s position as a high-growth category globally. Asia remained the largest export destination, with export value totaling 28.8 billion yen, representing an 8% increase year on year and accounting for 63% of total export value. North America recorded exports of 12.4 billion ye
Canva Brings On-Brand Designs Directly into AI Assistants6.2.2026 01:00:00 EET | Press release
The future of work is being rewritten by AI, with professionals accomplishing in minutes what used to take hours. But there's been one persistent breaking point in AI assistants: generic visual outputs and off-brand colors that undermine AI speed with tedious manual cleanup. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205384226/en/ Canva Today, that friction ends as Canva brings brand intelligence directly into the AI tools where modern day work happens most. Starting now, ChatGPT users can create designs completely tied to their Canva Brand Kit, making a company’s brand come to life visually and function as a living participant in AI workflows. This expansion marks the coming together of Canva and ChatGPT, two category-defining platforms, in a new way to make on-brand design more accessible and fluid. From client-ready pitch decks to social posts and professional-looking posters, the partnership continues to fuel Canv
DNIB.com Reports Internet Has 386.9 Million Domain Name Registrations at the End of the Fourth Quarter of 20256.2.2026 00:04:00 EET | Press release
VeriSign, Inc. (NASDAQ: VRSN), a global provider of critical internet infrastructure and domain name registry services, today announced that, according to the latest Domain Name Industry Brief Quarterly Report from DNIB.com, the fourth quarter of 2025 closed with 386.9 million domain name registrations across all top-level domains (TLDs), an increase of 8.4 million domain name registrations, or 2.2% compared to the third quarter of 2025. Domain name registrations also increased by 22.7 million, or 6.2%, year over year. The .com and .net TLDs had a combined total of 173.5 million domain name registrations in the domain name base at the end of the fourth quarter of 2025, an increase of 1.6 million domain name registrations, or 0.9% compared to the third quarter of 2025. The .com and .net TLDs had a combined increase of 4.5 million domain name registrations, or 2.6%, year over year. As of Dec. 31, 2025, the .com domain name base totaled 161.0 million domain name registrations and the .net
Calix CEO Michael Weening To Keynote at MWC26 Barcelona: How Agentic AI Enables an ‘Experience of One’ for Every Subscriber5.2.2026 21:30:00 EET | Press release
Calix, Inc. (NYSE: CALX) today announced that President and Chief Executive Officer Michael Weening will deliver a keynote in the Tuesday morning, March 3, “Architects of the AI Age” session at MWC26 Barcelona. Calix’s presence at MWC, the world’s largest and most influential connectivity event, extends the momentum following the recent launch of the company’s AI‑native platform. Weening will take the MWC Main Stage on Tuesday morning to reveal a transformative vision for telecommunications: how agentic AI enables service providers to deliver an “experience of one” to millions of subscribers simultaneously—personalizing every interaction in real time, unlocking new revenue streams, and fundamentally redefining what it means to grow in the connected world. He will be joined onstage by leading AI researcher and author Kate Crawford, a globally recognized voice in AI ethics, to explore how this transformation goes beyond automation. They will address how responsible agentic AI can amplify
Verimatrix: Sale of Extended Threat Defense Assets (Mobile Application Protection) to Guardsquare5.2.2026 18:45:00 EET | Press release
Regulatory News: Verimatrix, (Euronext Paris: VMX), a leading provider of security solutions for a safer connected world, today announced that it has completed the sale of 100% of its Extended Threat Defense (XTD) assets to Guardsquare, a Belgian company and leader in mobile application security. This transaction follows the signing of an agreement announced in a press release on December 8, 2025, as well as regulatory approval. It is part of Verimatrix's overall strategy to refocus on its core business, reflecting the group's strategic decision to concentrate on the key growth segments of the video protection market. Commenting on the announcement, Laurent Dechaux, CEO of Verimatrix, said: “Verimatrix has a strong technological foundation that enables our teams to pursue new business opportunities. Our priorities are to identify key growth drivers, address our clients’ needs effectively, and optimize resource allocation. I look forward to presenting these strategic initiatives to the
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