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 LYCRA Company to Successfully Complete Comprehensive Financial Restructuring20.5.2026 05:23:00 EEST | Press release
The LYCRA Company, LLC (“the Company”), a global leader in developing fiber and technology solutions for the apparel and personal care industries, will successfully complete its comprehensive financial restructuring process and emerge from Chapter 11 protection on May 20, 2026. The LYCRA Company has established a durable capital structure that will enable the Company’s pursuit of its growth strategy through investment in innovation, customer partnerships, and global operations. The Company will emerge from its comprehensive restructuring process with significantly enhanced financial flexibility and a strengthened balance sheet to support long-term growth. The Company will have reduced its total long-term debt by more than $1.2 billion and will obtain more than $75 million in new money investment. Throughout the process, the Company has maintained uninterrupted operations and continues to deliver on commitments to its employees, customers, and vendors. The LYCRA Company will be supporte
Johns Manville Announces John Vasuta as New CEO19.5.2026 23:30:00 EEST | Press release
Johns Manville (JM), a global building and specialty products manufacturer and a Berkshire Hathaway company, announced today that Bob Wamboldt will retire and John Vasuta will assume the role of President and Chief Executive Officer, effective August 1, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519630814/en/ John Vasuta will become JM's CEO and President on August 1, 2026. Vasuta joined Johns Manville in 2019 as President of the company’s Engineered Products business. He also serves on the Board of Directors for EJ, a global leader and private manufacturer of infrastructure access products for water, sewer, utilities, drainage and telecommunications. “It’s an extraordinary privilege to step into the role of CEO,” Vasuta said. “I’m deeply honored to continue serving our customers and supporting the employees whose dedication makes our success possible.” Before joining JM, John held leadership roles at Bridgeston
Mereo Insurance Announces Move into Excess Casualty Insurance19.5.2026 23:12:00 EEST | Press release
Mereo Insurance Limited (“Mereo”) today announced a renewal rights transaction with Everen Specialty Ltd. (“ESL”), a member of the Everen Group, for ESL’s Excess Casualty Energy portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519154915/en/ David Croom-Johnson, President & Chief Executive Officer of Mereo Insurance Limited Under the transaction, Mereo will become the insurance carrier on a go-forward basis for both new and renewed business effective June 1, 2026. ESL’s underwriting team and underwriting systems supporting the Excess Casualty Energy portfolio will also transition to Mereo, led by former ESL Chief Underwriting Officer, Carla Greaves. Under the terms of the agreement, Mereo will provide ESL insureds with continuity of coverage, access to AM Best “A- rated” paper, and the support of Mereo’s strong capital base, while ESL will service claims, ensuring that insureds continue to benefit from ESL’s promp
Grid Dynamics Launches AI-Native Modernization on Azure, Targeting Larger Enterprise Deals19.5.2026 23:05:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, today announced an AI-native modernization service offering on Microsoft Azure, powered by its GAIN Platform for SDLC. The offering targets large enterprise clients running mission-critical, high-transaction-volume legacy environments. By tackling their biggest roadblocks—technical debt and legacy licensing costs—it addresses a market segment known for larger contracts and stronger margins. Microsoft reported that Azure revenue surpassed $75 billion in 2025, up 34% year-over-year, reflecting strong and accelerating enterprise migration demand. Grid Dynamics, a Microsoft Azure specialized partner with five advanced specializations, including Infra and Database Migration, is built to capture this opportunity. Through the Azure Accelerate program, Grid Dynamics clients benefit from free Microsoft deployment assistance, Azure credits, partner funding, and funded migratio
Vultr Expands European Footprint with 33rd Cloud Data Center Region in Milan, Italy19.5.2026 18:28:00 EEST | Press release
Vultr, the world’s largest privately-held cloud infrastructure company, today announces the launch of its 33rd global cloud data center region in Milan, coinciding with AI Week 2026 at Fiera Milano Rho, where over 700 international speakers will gather for Europe's largest AI event. Vultr is a platinum sponsor and is also co-hosting the AI Agent Olympics Hackathon with over 1,000 participants. Milan becomes Vultr's ninth European cloud data center region, joining Amsterdam, Frankfurt, London, Madrid, Manchester, Paris, Stockholm, and Warsaw. This launch represents the company's latest expansion of a global network reaching 90% of the world's population within 2–40 milliseconds. Vultr’s cloud data center location will be delivering Vultr’s full-stack AI infrastructure, including Vultr’s flagship cloud compute offering, VX1, in addition to Vultr’s full range of bare metal and cloud GPU offerings from NVIDIA and AMD. The region will serve enterprises and developers running demanding workl
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