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
The Estée Lauder Companies Announces BEAUTY&YOU India 2026 Winners and Marks Five Years of Advancing Indian Beauty Entrepreneurship15.10.2026 18:58:00 EEST | Press release
The Estée Lauder Companies, in partnership with Nykaa and Startup India, an initiative of the Department for Promotion of Industry and Internal Trade (DPIIT) within India’s Ministry of Commerce and Industry, announced the winners of BEAUTY&YOU India 2026, the country’s leading beauty entrepreneurship program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015612324/en/ (L to R) BEAUTY&YOU India 2026 Winners Ajaykumar Mehta, Shriya Rambhia, and Dheer Rambhia, Directors, Goyam Green Tech (BREAKTHROUGH), Nirja Bhatt, Founder & CEO, Laani (GROW), Khatija Shabana, CEO, and Syed Mohammad Fouzan, Director, Boldpurity (IMAGINE), Rinzing Choden Bhutia, Founder, Agapi Sikkim (Visionary Women’s Award), and Pankti Sheth, Founder & Creative Director, De Icebreaker Creative Studio (DESIGN). For five years, BEAUTY&YOU India has discovered, supported, and accelerated India’s next generation of beauty entrepreneurs. Since launching in 202
BioLab Holdings Launches EmeraNova™ to Advance the Future of Tissue Restoration15.10.2026 18:00:00 EEST | Press release
BioLab Holdings announced today a new, larger mission with the launch of EmeraNova™, a new corporate identity that reflects a broader ambition to advance tissue restoration across specialties, healing phases, and care settings. The launch marks the company’s efforts to build a global platform focused on identifying promising technologies and accelerating their path into clinical practice. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015721831/en/ EmeraNova seeks partners around the world to bring promising technologies to market quickly and equip clinicians with advanced, effective solutions. EmeraNova represents a vision to pursue emerging (Emer) and new (Nova) technologies by building an expanding toolbox of tissue restoration solutions, world-class support, and ways to bring together expert voices and clinical insights that will help shape what comes next. The company’s roots in chronic wound care will inform its fut
Body of Waves , a New Artwork Only at teamLab Planets TOKYO, Unveiled15.10.2026 18:00:00 EEST | Press release
teamLab Planets TOKYO (hereinafter referred to as “teamLab Planets”) has unveiled Body of Waves, a new artwork in which visitors enter a soft sculpture with their entire bodies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014474897/en/ teamLab, Body of Waves, 2026, from the series Soft Black Hole - Your Body Becomes a Space that Influences Another Body, 2016-© teamLab *Shot in real space. No AI or CGI. In addition, Existence in the Flow Creates Vortices—where vortices are created behind people as they climb against the flow—and Waterfall of Ephemeral Crystals—where shining particles cascade down to create a waterfall of light particles—have also evolved, further expanding the experience at teamLab Planets. New Artwork Body of Waves As you walk, your feet sink. This force is transmitted to the large, soft and flexible sculpture spreading across the floor, causing the sculpture to physically deform. The force generated b
CTIBIOTECH™ Announces Strategic Partnership and MOU With Beijing Vital River to Advance Preclinical Biomedical Innovation in China15.10.2026 17:59:00 EEST | Press release
CTIBIOTECH™, a pioneering Contract Research, Development, and Manufacturing Organization (CRDMO) and global leader in 3D bioprinting of human tissues, today announces the signing of a Memorandum of Understanding (MOU) and strategic partnership with Beijing Vital River, a Charles River company and provider of research models and associated preclinical services in China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014604195/en/ CTIBIOTECH signs strategic partnership with Beijing Vital River, a Charles River Laboratories company for commercialization of human tissue bioassays and New Approach Methodologies (NAMs) in Popular Republic of China The agreement was signed in Shanghai during the Shanghai – Auvergne-Rhône-Alpes Economic Dialogue, organized by the Nouvel Institut Franco-Chinois (NIFC), as part of the official Auvergne-Rhône-Alpes Region delegation to China. This alliance is designed to bring CTIBIOTECH™'s unique p
Navan Unveils New Ways to Book, Expense, and Travel at Navigate Europe 202615.10.2026 17:30:00 EEST | Press release
Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, unveiled a new set of capabilities and product updates at Navigate Europe, its flagship customer conference. The updates bring Navan into more workplace tools, expand card issuing to new currencies, and simplify guest reimbursement, all while giving businesses greater visibility and control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015250476/en/ “Business never stands still. Our customers are constantly expanding and expecting more value, which is why we continue to innovate and elevate every part of the employee experience,” said Michael Riegel, Chief Customer Officer at Navan. “We’ve spent years building the global technology infrastructure and expertise to make travel and expense work better. These new capabilities will support more users in more ways than ever before, all from one connected platform that moves as fast as they do.”
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