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
Navan Drives Global Travel and Expense Efficiencies at Viessmann Generations Group23.6.2026 11:01:00 EEST | Press release
Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced its collaboration with Viessmann Generations Group, a global family company with 109 years of entrepreneurial heritage, guided by the purpose of co-creating living spheres for generations to come. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623797613/en/ Global purpose-driven family company improves transparency, cost control and employee experience with Navan Since implementing Navan in 2023, Viessmann Generations Group has increased transparency, reduced manual effort and improved the employee experience across travel and expense. Before partnering with Navan, Viessmann Generations Group managed travel and expense processes across several tools and workflows. Employees faced long support wait times, while the finance team handled manual expense processing at the end of each month. “With Navan, we’ve digitized the entire
ISOPLUS Selects Navan to Consolidate Global Travel and Expense Operations23.6.2026 11:00:00 EEST | Press release
Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced it has been selected by ISOPLUS, a leading manufacturer of pre-insulated pipe systems for district heating and cooling, to consolidate its global travel and expense program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623669736/en/ Leading manufacturer of pipe systems deploys AI-powered platform to establish policy control, eliminate manual accounting, and drive measurable cost savings Following the success of Navan’s partnership with the wider Viessmann Generations Group, ISOPLUS has chosen to consolidate its travel and expense operations with Navan – moving away from significant unmanaged travel and expense. “Navan automates that tedious work and gives us the real-time financial control we need to run a tighter, more efficient business,” said Dirk Seibert, Head of Group Legal & HR, and Chief Compliance Officer, ISOPLUS.
Infobip and Digitas Middle East Sign Expansion of Their Strategic Partnership to Power AI-Driven Customer Engagement for Global Brands23.6.2026 11:00:00 EEST | Press release
The global AI-first cloud communications platform Infobip, today announced a partnership with Digitas, the Marketing Transformation arm of the Publicis Groupe, the world's foremost communications agency holding group. Under the partnership, Infobip and Digitas ME will build a joint service practice around the Infobip AgentOS platform, bringing together Infobip's enterprise communications infrastructure and Publicis Groupe’s deep capabilities in data, AI, customer experience strategy, and media transformation. The partnership is supported by a global framework agreement with the roll out starting across MENA and APAC initially. The collaboration addresses a growing need: bringing together marketing transformation, AI-driven personalisation, and real-time business messaging into a single, coherent customer experience. Where Publicis Groupe shapes how global brands engage their customers, across media, data, loyalty, and commerce, Infobip provides the communication infrastructure to make
Hytera Launches W60 Wearable MCS Radio to Extend Mission-Critical Communication Beyond PMR Coverage23.6.2026 10:58:00 EEST | Press release
Hytera, a leading global provider of critical communications technologies and solutions, launched the W60 Wearable MCS Radio at Critical Communications World (CCW) 2026. Designed to complement existing PMR systems, the lightweight wearable device helps organizations maintain mission-critical communications beyond the coverage limits of traditional radio networks, supporting safer and more connected operations across public safety, transportation, energy, and industrial sectors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622677096/en/ W60 Wearable MCS Radio for connected operations beyond PMR coverage Extending Communication Beyond PMR Coverage Maintaining reliable communications in basements, tunnels, underground facilities, and other hard-to-cover environments remains a challenge for many organizations. Expanding PMR infrastructure in these locations often requires significant investment and deployment time. The W60
Samsung Unveils Industry's Fastest UFS 5.0 Solution for Next-Gen On-Device AI Applications23.6.2026 10:10:00 EEST | Press release
Samsung Electronics Co., Ltd., the world leader in advanced memory technology today announced that, for the first time in the industry, it has developed the industry's fastest Universal Flash Storage (UFS) 5.0 solution, which will help enable seamless and highly efficient AI services on future mobile devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623632789/en/ Samsung Unveils Industry's Fastest UFS 5.0 Solution for Next-Gen On-Device AI Applications The milestone sets a new benchmark for the next-generation mobile memory market as the enhanced performance is expected to allow mobile device users with significantly reduced latency and faster response times when running large language models (LLMs) in on-device AI environments "In the era of on-device AI, storage devices are evolving into a key driver defining AI experiences," said Jangseok Choi, head of Memory Product Planning at Samsung Electronics. "As we succes
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