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
FlexGen Launches International Operations, Delivering Software and Services to Meet Demand for Battery Storage in Europe17.6.2026 15:00:00 EEST | Press release
FlexGen Power Systems, LLC. ("FlexGen"), a leading battery energy storage solution and energy management software provider, announced today that it continues to grow its global business by building its presence in Europe to increase battery storage capacity on local grids, supporting energy reliability and affordability. FlexGen offers its energy management system, including power plant controls (PPC), analytics, and site-level supervisory control and data acquisition (SCADA), as well as services, such as lifecycle services, integration abilities, and data centre leadership, to the European market to improve operational performance, increase availability, and unlock greater returns for battery storage developers and operators. “As Europe faces rising energy prices, high curtailment rates, and rising demand from electrification, FlexGen’s advanced software and services will meet local grid challenges and solve for energy independence, reliability, and affordability,” said Mike Wallace,
Moody’s Launches Decision-Grade AI Skills for Major AI Platforms17.6.2026 15:00:00 EEST | Press release
Moody’s Corporation (NYSE: MCO) today announced the release of its first set of AI skills – purpose-built, platform-agnostic instruction kits that encode Moody’s analytical frameworks and connect AI agents to its decision-grade intelligence. Available across compatible AI platforms beginning with Microsoft 365 Copilot Cowork, Moody’s skills enable customers to execute complex analytical workflows through a single natural-language request, with outputs grounded in Moody’s proprietary ratings, research, and risk intelligence. “Moody’s is among the first financial data providers to deliver a full library of skills on an open standard, and today’s launch is just the beginning,” said Cristina Pieretti, Head of Digital Content and Innovation at Moody’s. “AI platforms are becoming the interface for financial decision-making, and the next phase of adoption will be defined by execution. Skills are how we encode Moody’s expertise into that execution layer.” Skills are emerging as the standard fo
Rehlko and Liebherr Partner on Strategic Capacity Expansion to Support Accelerating Data Center Demand for Resilient Power Solutions17.6.2026 15:00:00 EEST | Press release
Rehlko, a global energy resilience leader delivering innovative solutions across industrial energy systems, powertrain technologies, and home energy applications, joined Liebherr Group (“Liebherr”) on June 2 for the strategic capacity expansion ceremony at the Liebherr-Components facility in Colmar, France. This event marks a key milestone in the continued expansion of Rehlko’s strategic partnership with Liebherr and a significant step in scaling resilient power solutions for the next generation of digital infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617213506/en/ Liebherr and Rehlko celebrate the strategic capacity expansion of Liebherr-Components Colmar factory. From left to right: Brian Melka (President and CEO of Rehlko), Jan Liebherr (President of the Administrative Board of Liebherr-International AG), Pietro Iemmi (CEO Liebherr-Component Technologies AG), and further members of Rehlko’s and Liebher
Thredd and Sutton Bank Partner to Power U.S. Card Program Expansion for Global Brands17.6.2026 15:00:00 EEST | Press release
Thredd, the AI-first issuer processing platform, today announced a strategic partnership with Sutton Bank, a leading sponsor bank and card issuer for fintechs and embedded finance use cases. Through the partnership, Sutton Bank will serve as a BIN sponsor for Thredd clients seeking to launch and scale prepaid and debit card programs in the United States. The partnership strengthens the U.S. market proposition for global fintechs and embedded finance providers by providing these organizations access to an established U.S. issuing bank partner with a long-standing track record supporting card programs across the fintech ecosystem. Sutton Bank has become widely recognized for its payments business, including its work with card networks, processors and program managers, as well as its role as a large BIN sponsor for the fintech community. Together, Thredd and Sutton Bank will support companies looking to bring modern prepaid and debit card programs to market across the U.S. Thredd will pro
FEINDEF 27 Accelerates Commercialisation, Surpassing FEINDEF 25’s Total Exhibition Area by 25% With One Year to Go17.6.2026 14:41:00 EEST | Press release
One year ahead of FEINDEF 27, FEINDEF, Spain’s International Defence and Security Exhibition, continues to maintain a strong commercialisation pace, outperforming previous editions at the same stage. The exhibition has already surpassed the total exhibition area occupied at FEINDEF 25 by 25%, reflecting the strong interest across the sector in participating in the next edition and reinforcing its appeal amid the continued growth of the defence and security industry. Organised by the Fundación Feindef, the exhibition will hold its fifth edition from 18 to 20 May 2027 at IFEMA Madrid, with the objective of consolidating a new phase of growth and strengthening its position as a leading international platform bringing together institutions, industry stakeholders and professionals from across the defence and security ecosystem. In this context, FEINDEF 27 is expected to exceed 89,000 m² of total exhibition area, representing a 46% increase compared to FEINDEF 25 and expanding its capacity t
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