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 Estée Lauder Companies Unveils Mastering Skin Longevity, a Breakthrough Scientific Innovation Platform Advancing the Next Era of Skin Science6.11.2026 16:00:00 EET | Press release
At the China International Import Expo (CIIE), The Estée Lauder Companies Inc. (NYSE: EL) today unveiled Mastering Skin Longevity, a breakthrough scientific innovation platform designed to advance the next era of skin science and transformative product innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261106776704/en/ The Estée Lauder Companies' Skin Longevity Clock serves as the visual representation for the Mastering Skin Longevity scientific innovation platform. Moving beyond the study of individual Hallmarks of Aging, the platform focuses further upstream on the Master Regulators of Skin Longevity. These interconnected biological pathways and proteins influence multiple hallmarks at once. By deepening understanding of these systems and how they help support skin’s ability to repair, adapt and regenerate, Mastering Skin Longevity will guide the Company’s discovery across ingredients, technologies, formulations an
IntouchCX Recognized for Operations led AI and End to End CX Transformation by HFS Research6.11.2026 16:00:00 EET | Press release
IntouchCX a global leader in AI-powered customer experience (CX) management, trust and safety, digital engagement, and back-office operations, has been positioned in the Horizon 2 end-to-end experience transformation, in the HFS Horizons Customer Experience Services 2026 report for its operations led approach to AI adoption and its model connecting advisory with delivery, from strategy through frontline executions. HFS Research evaluates customer experience service providers based on their capabilities, innovation, and potential to deliver value. The 2026 report examines how providers are helping businesses adopt AI, improve customer experiences and strengthen operations. “AI transformation delivers the greatest value when strategy, technology, and operations work together,” said Brent Stevenson, Chief Experience Officer at IntouchCX. “Our approach and expertise goes beyond technology. We identify business challenges and build the right solutions by connecting the dots between data, wo
Experian Named a Leader in 2026 IDC MarketScape for Worldwide Decision Intelligence Platforms6.11.2026 16:00:00 EET | Press release
Experian today announced it has been named a Leader in the IDC MarketScape: Worldwide Decision Intelligence Platforms 2026 Vendor Assessment (Doc #US54118426, September 2026), which evaluates providers helping organizations design, engineer and orchestrate increasingly complex decisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261106302874/en/ IDC MarketScape positions Experian as a Leader in its 2026 vendor assessment of worldwide decision intelligence platform providers. “As organizations embed AI into more consequential decisions, the combination of trusted data, advanced analytics and strong governance becomes increasingly important,” said Keith Little, President of Experian Software Solutions. “Experian brings those capabilities together with decisioning, fraud and identity to help organizations make better decisions with greater speed and confidence.” The Experian Ascend Platform provides a unified analytics and
Midas Atlantic Partners, in Partnership With the Najafi Companies, Has Entered Into a Put Option Agreement With Sylvamo Relating to the Potential Acquisition of Its European Operations6.11.2026 13:04:00 EET | Press release
Midas Atlantic Partners (“Midas Atlantic”), in partnership with The Najafi Companies, has signed a put option agreement with Sylvamo Corporation (“Sylvamo”) relating to the potential acquisition of its European operations (the “Business”). The transaction comprises Sylvamo’s uncoated freesheet paper mills in Saillat and Nymölla, as well as its forestry and supporting business operations across Europe. Closing is expected in the first quarter of 2027, once the required consultation processes are completed and regulatory approvals are obtained. The Business is a leading European producer of uncoated woodfree (UWF) paper for office and commercial printing. Its product portfolio spans cut-size office paper, sold under its own brands such as REY and Multicopy as well as on behalf of major OEM and office supplies customers, and paper reels for commercial printers and converters. Headquartered in Belgium, with two large-scale, vertically integrated pulp and paper mills, it serves a longstandi
Suzano Reports 36% Increase in Third Quarter Net Revenue Following Consolidation of Arbex6.11.2026 01:23:00 EET | Press release
Suzano (B3: SUZB3 / NYSE: SUZ) , the world’s largest pulp producer, announces its results for the third quarter of 2026 (3Q26), which for the first time include Arbex, the joint venture between Suzano and Kimberly-Clark established in July this year. Driven primarily by the consolidation of Arbex’s contribution, Suzano reported net revenue of BRL16.5 billion, an increase of 36% on the same period last year and a new quarterly record in the company’s 102-year history. Adjusted EBITDA totaled R$5.7 billion in 3Q26, up 9% on the same basis of comparison. Operating cash generation reached R$3.8 billion, an increase of 12%. Net income totaled R$2.1 billion. As announced following the completion of the transaction with Kimberly-Clark, Suzano holds a 51% equity interest in Arbex and will therefore fully consolidate the joint venture’s financial statements from this quarter onwards.1 “This quarter marks the beginning of a new phase for Suzano. With Arbex, we are now a broader business, both ge
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