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
NetApp Helps Customers Accelerate Adoption of Latest VMware Cloud Foundation Innovations2.9.2026 23:30:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, announced new capabilities in NetApp ONTAP® have been tested and validated to support VMware Cloud Foundation (VCF) 9.1, giving customers an optimized and secure data infrastructure foundation for their private and hybrid clouds. By combining the advanced capabilities of VCF 9.1 with cost-effective and enterprise data management with built-in security features from NetApp, including safeguarding data against ransomware attacks with rapid recovery, mutual customers can lower costs and accelerate the deployment of their AI software into production. VMware Cloud Foundation 9.1 provides enterprises with a unified private cloud platform for running both traditional and modern workloads. NetApp's solutions are tested and validated to support VCF 9.1 environments, enabling mutual customers to immediately begin taking advantage of VCF 9.1 innovations when they upgrade, with a data infrastructure layer already proven to work w
Venture Global Announces Closing of $3,000,000,000 364-Day Senior Secured Revolving Credit Facility2.9.2026 23:30:00 EEST | Press release
Venture Global, Inc. (“Venture Global”) announced today that its subsidiary Venture Global LNG, Inc. (“VGLNG”) has entered into a new, $3,000,000,000 364-day revolving credit facility (the “Facility”). Venture Global expects to use the proceeds from borrowings under the Facility for general corporate purposes of VGLNG and its subsidiaries, including to fund certain project costs for the CP2 and Plaquemines bolt-on expansions prior to their respective FIDs. Bank of America, N.A. served as Coordinating Lead Arranger and Sole Bookrunner and will also serve as Administrative Agent. BBVA, Goldman Sachs, ING, J.P. Morgan, Mizuho, MUFG, NBC, RBC, Scotia, SMBC, U.S. Bank, and Wells Fargo served as Coordinating Lead Arrangers and Barclays, Santander, and Deutsche Bank served as Joint Lead Arrangers. About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (LNG) with over 100 MTPA of capacity in production, construction, or development. Vent
Invivoscribe Begins Commercial Shipments of PrepQuant ™ Systems, Enabling High-Sensitivity Sample Preparation for MRD Testing2.9.2026 22:31:00 EEST | Press release
Invivoscribe®, a global leader in precision diagnostics and measurable residual disease (MRD) testing, today announced that commercial shipments of the PrepQuant™ System have begun in North America. First unveiled at the American Association for Cancer Research Annual Meeting in April 2026, PrepQuant is now being delivered to customers, marking the platform's progression from development and validation into commercial deployment. The commercial milestone extends Invivoscribe's capabilities into laboratory instrumentation and addresses a critical bottleneck in highly sensitive molecular testing: efficiently recovering, concentrating, and quantifying DNA from larger blood and plasma inputs. PrepQuant is assay agnostic, designed to produce concentrated genomic DNA and cell-free DNA (cfDNA) suitable for a full range of downstream molecular workflows, including MRD assays intended to detect very low levels of residual disease. MRD Sensitivity Starts Before the Assay As MRD testing moves tow
C.H. Guenther Opens Centre of Excellence in Coventry, UK to Accelerate Bakery Innovation and Support Future Manufacturing Growth Across UK and Europe2.9.2026 19:00:00 EEST | Press release
C.H. Guenther & Son LLC (“C.H. Guenther” or “CHG”), a leading food manufacturer, has opened a new Centre of Excellence (the “Centre”) at its flagship Coventry bakery, creating a dedicated innovation and customer collaboration hub designed to accelerate the development of premium bakery products across the UK and Europe. The new facility has been designed to support CHG’s customers including leading global quick service restaurants, foodservice operators and retailers as they develop, test and refine new bakery products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902696890/en/ The purpose-built, 172-square-metre Centre of Excellence brings together a commercial-scale bakery, customer demonstration kitchen, sensory evaluation facilities, innovation suite and dedicated collaboration spaces in one specialized location. Designed to support and accelerate product development from concept through to commercial manufacturing,
Record Asset Management Enters New Phase of Growth2.9.2026 18:35:00 EEST | Press release
Record Asset Management GmbH (“RAM”), a subsidiary of London-listed Record plc (“Record” or the “Group”), is pleased to announce that it is now operating cashflow positive, thereby marking a transition from its investment phase into a growth business within the Group, and a significant milestone towards sustainable profitability. RAM is the European asset management arm of Record, the London-listed specialist investment group managing USD 122 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. RAM was established as a sister company to Record’s core currency business and obtained its BaFin license in 2022. RAM has grown rapidly in the last two years and has developed into a diversified private markets platform with dedicated infrastructure e
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