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
Japan's Cross-Border E-Commerce "WAFUU.COM" Unveils Official Mascot Character "Mochi"22.7.2026 11:00:00 EEST | Press release
QRESTIA Inc. (Headquarters: Shibuya, Tokyo; President & CEO: Hidemasa Fukada) is pleased to announce that WAFUU.COM, its cross-border e-commerce site, has unveiled its new official mascot character, Mochi. Mochi will represent WAFUU.COM's warmth and friendliness across its website, social media, campaigns, package inserts, and other creative materials, connecting with fans everywhere. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721435469/en/ Mochi, WAFUU.COM's new official mascot character, embodies "A tiny happiness from Japan." (Photo: WAFUU.COM) The debut video is now live on Mochi's official website: https://mochi.wafuu.com/ 1. About Mochi Mochi was born to embody the simple joy of choosing Japanese products. Its soft, rounded silhouette, gentle expression, and distinctive, endearing details are designed to feel welcoming to first-time visitors and longtime fans of Japanese culture alike — a character people will w
New NEURA Gym with RWTH Aachen: NEURA Robotics Expands its Global Training Network for Physical AI22.7.2026 10:10:00 EEST | Press release
NEURA Robotics ("NEURA"), the pioneer in cognitive robotics and creator of the Neuraverse, today announces a new partnership with RWTH Aachen University for the establishment of NEURA Gym RWTH Aachen. This continues the global rollout of NEURA Gyms, a worldwide network of purpose-built Physical AI training facilities that address the most significant barrier to intelligent robotics: the scarcity of real-world training data. The global rollout is backed by NEURA's Series C financing of up to $1.4 billion, the largest ever raised by a full-stack robotics company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721136838/en/ New NEURA Gym with RWTH Aachen: NEURA Robotics Expands its Global Training Network for Physical AI While ten NEURA Gyms are currently under development, five locations across Europe, the United States and China will be operational by end of 2026. The network is anchored by the two European flagship Univer
Specright Launches Automated PPWR Declaration of Conformity Reporting22.7.2026 07:00:00 EEST | Press release
Specright™, the leader in AI-powered Specification Data Management™ (SDM) and modern Product Lifecycle Management (PLM), today announced a new Declaration of Conformity (DoC) reporting capability that automates a core requirement of the EU's Packaging and Packaging Waste Regulation (PPWR). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721689027/en/ Specright's new capability automates PPWR Declaration of Conformity reporting ahead of the EU's August 2026 deadline. Companies placing packaged goods on the EU market must produce a signed DoC starting August 12, 2026, covering PPWR Articles 5 through 12 — substance restrictions, recyclability, recycled content, minimization, reusability, and labeling. For most brands, that documentation is scattered across suppliers and spreadsheets, turning routine filings into monthslong searches. "This launch builds on our EMEA investments this past year — from the PPWR-ready packaging in
MediaCo Appoints Brian Fisher as President21.7.2026 23:15:00 EEST | Press release
MediaCo Holding Inc. (Nasdaq: MDIA) today announced executive leadership appointments that align the Company's leadership structure to support its long-term growth strategy. Effective immediately, Brian Fisher has been appointed President of MediaCo. Albert Rodriguez will continue to serve as Chief Executive Officer, focusing on the Company's long-term strategy, growth initiatives and shareholder value, while Fisher assumes responsibility for leading the Company's day-to-day operations and execution. The Company also announced that Roberto Castro has been appointed Interim Chief Financial Officer and Interim Treasurer, overseeing the Finance organization while a search is conducted for a permanent Chief Financial Officer. "MediaCo has built tremendous momentum, and these leadership appointments position us well for our next phase of growth," said Albert Rodriguez, Chief Executive Officer of MediaCo. "Brian is the right leader to serve as President, and Roberto's financial expertise wil
Footprint Expands Into PE-Free Cups, Bringing a Proven, Recyclable and Home-Compostable Alternative to Plastic-Lined Paper Cups Into Production21.7.2026 19:00:00 EEST | Press release
Footprint, a materials science and technology company focused on eliminating single-use plastics, today announced it has acquired a recyclable, home-compostable, polyethylene (PE)-free hot and cold cup platform from Transcend Packaging, along with next-generation paper lid and straw solutions. Transcend Packaging is a European company focused on innovation in sustainable packaging solutions. Together, the cup, lid, and straw expand Footprint’s portfolio with a proven solution for the global cup market. Footprint will begin scaling its new PE-free solution through its Poland facility as the company expands across Europe, with North America to follow. As operations ramp in Poland, Footprint will work with Transcend through a manufacturing partnership to support customer continuity across Europe and meet growing demand for practical alternatives to plastic-lined cups. Transcend will manufacture product from its Wales facility for Footprint customers, while continuing to serve customers in
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