ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
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
Lattice Wins 2025 Global Semiconductor Alliance Award6.12.2025 01:49:00 EET | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced that it was selected as ‘Most Respected Public Semiconductor Company’ at the 2025 Global Semiconductor Alliance (GSA) Awards. The GSA awards recognize companies that have demonstrated excellence through their success, vision, strategy, and future opportunities in the industry as determined by votes from GSA members. “We are honored to be recognized by the Global Semiconductor Alliance and our peers as one of 2025’s most respected public semiconductor companies. This recognition reflects the dedication of the Lattice team and the trust of our customers, partners, suppliers, and investors. Looking ahead, we remain laser-focused on driving innovation and strengthening our role as the trusted low power programmable leader for semiconductor and system solutions,” said Ford Tamer, Chief Executive Officer, Lattice Semiconductor. The annual GSA Awards celebrate the accomplishments of the semiconductor indu
Fitch Learning Completes Acquisition of Moody’s Analytics Learning Solutions and the Canadian Securities Institute5.12.2025 17:48:00 EET | Press release
Fitch Learning, the global leader in financial learning and professional certifications, today announced the completion of its acquisition of Moody’s Analytics Learning Solutions (MALS) and the Canadian Securities Institute (CSI). MALS is a global provider of credit and digital learning, and CSI is a leading provider of certifications for the Canadian financial services industry. Fitch Learning, recognized globally as the premier financial education provider, delivers specialized training for the financial services industry through accredited qualifications, flexible corporate solutions programs, managed services and digital learning solutions trusted by leading institutions worldwide. The combined business will serve over 92,000 finance professionals across 148 countries, at every stage of their careers. “This acquisition is about creating more opportunities for growth – for organizations and for individuals,” said Andreas Karaiskos, CEO of Fitch Learning. “By combining both organizat
Arthur D. Little and Vega IT Unveil Joint Venture for Digital Innovation5.12.2025 17:00:00 EET | Press release
Arthur D. Little (ADL) and Vega IT today announced the formation of Axceler8 Solutions, a 50/50 joint venture created to design, develop, and operate a portfolio of digital and AI solutions aimed at improving efficiency and automating complex business processes. The launch of this new company is the direct outcome of a year of successful collaboration between the two firms and marks a new phase in their shared ambition to bring scalable, high-performance digital solutions to market, aiming to further augment their clients’ capacity to compress time to impact in a variety of domains. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251205465303/en/ Arthur D. Little and Vega IT have announced the formation of Axceler8 Solutions, a 50/50 joint venture created to design, develop, and operate a portfolio of digital and AI solutions. Axceler8 Solutions’ first product, Axceler8 Rx, is now live as a newly developed platform, and is a
Lone Star Announces Sale of SPX FLOW to ITT Inc.5.12.2025 14:30:00 EET | Press release
Lone Star Funds (“Lone Star”) today announced the signing by an affiliate of Lone Star Fund XI, LP of a definitive agreement to sell SPX FLOW, Inc. (“SPX FLOW”), a leading provider of highly engineered equipment and process technologies for attractive end markets including industrial, health and nutrition, to ITT Inc. (NYSE: ITT) for $4.775 billion in cash and shares of common stock. Based in Charlotte, N.C., SPX FLOW focuses on process technologies delivering mixing, blending, fluid handling, separation, thermal heat transfer and other solutions integral to industrial, health and nutrition markets. The company has operations in more than 25 countries and sales in more than 140 countries. In partnership with Lone Star, SPX FLOW has focused on improving its sales execution and operating platform, while ensuring high quality and innovative product development. The management team has improved the company’s commercial organization and executed growth initiatives to build its presence in e
AmTrust Financial Services and Blackstone Credit & Insurance Close Strategic Transaction and Launch Newly Formed Multinational MGA Company Named ANV Group Holdings Ltd.5.12.2025 14:00:00 EET | Press release
AmTrust Financial Services, Inc. (“AmTrust” or the “Company”), a global specialty property casualty insurer, and Blackstone Credit & Insurance (“BXCI”), today announced the closing of a strategic transaction under which AmTrust and funds managed by BXCI have partnered to spin-off certain of AmTrust’s Managing General Agencies (“MGAs”) and fee-based businesses in the U.S., United Kingdom, and Continental Europe, into ANV Group Holdings Ltd. (“ANV”), a newly formed independent company, following receipt of regulatory approvals. AmTrust and ANV have entered into a ten-year capacity agreement through which AmTrust will remain the underwriter for the existing books of business offered through the MGAs. As previously announced on September 15, 2025, the agreement includes seven AmTrust subsidiaries: ANV Specialty, Risico, Collegiate, ANV Nordic, Arc Legal, Qualis, and Abacus. These businesses provide diverse risk and insurance coverages including cyber excess and surplus (E&S), directors and
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