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 Acquires DataPelago, Making Data AI-Ready at the Infrastructure Layer16.7.2026 19:30:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced it has acquired DataPelago, a California-based AI data infrastructure company recognized for its innovative approach to eliminating data processing bottlenecks for AI and analytics workloads. The acquisition marks a foundational expansion of NetApp's portfolio, enabling GPU-accelerated data processing aligned directly with the storage layer. With this acquisition, NetApp establishes itself as the company that makes zero-copy activation of enterprise data for AI real. AI is the defining platform shift of our era, but enterprises are discovering that their greatest bottleneck is preparing, governing, and activating their data fast enough to put AI into production. The key to accomplishing this objective is to enable accelerated computing where the data is created and stored. DataPelago solves this challenge by fundamentally reimagining where accelerated compute happens: at the data layer, not above it. "
Visa Introduces Platform for Stablecoin Minting, Movement and Management16.7.2026 17:30:00 EEST | Press release
Today, Visa (NYSE: V) announced the Visa Stablecoin Platform (VSP), a new enterprise platform designed to help financial institutions, fintechs, and crypto natives access stablecoin capabilities through a single Visa-managed environment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716292689/en/ Building on Visa’s broader crypto strategy, VSP gives FIs, fintechs and other payment providers a simple way to access, store, and redeem stablecoins, beginning with Open USD (OUSD), a new stablecoin recently introduced by Open Standard. This includes onchain wallet infrastructure through a newly introduced Wallet-as-a-Service offering and connectivity for minting and burning Open USD. “Stablecoins are opening up a new layer of programmable money, but for most institutions the hard part isn’t the concept, it’s the operational reality,” said Jack Forestell, Chief Product and Strategy Officer, Visa. “With the Visa Stablecoin Platf
Andersen Consulting Adds Collaborating Firm Smartbridge16.7.2026 16:30:00 EEST | Press release
Andersen Consulting announces a Collaboration Agreement with Smartbridge, a Texas-based digital and AI technology firm, enhancing its capabilities in data and analytics, and digital transformation services. Founded in 2003, Smartbridge helps organizations accelerate their digital transformation and modernize operations through digital innovation, AI, data and analytics, and application modernization services. The firm works with clients in the oil and gas, medtech, and restaurant industries, combining advisory and technology services to enable enterprise transformation and growth. Leveraging strategic relationships with leading technology providers, Smartbridge helps organizations connect data, improve decision-making, and accelerate business outcomes. “Organizations today are looking to accelerate their digital and AI transformation and are searching for practical ways to translate innovation into measurable business value,” said Sri Raju, CEO of Smartbridge. “Our team focuses on help
Cyclic Materials Appoints Tomasz Poznar as Chief Commercial Officer to Accelerate Global Commercial Growth16.7.2026 16:20:00 EEST | Press release
Cyclic Materials, the rare earth recycling company building a circular supply chain for rare earth elements and critical materials, today announced the appointment of Tomasz Poznar, Ph.D., as Chief Commercial Officer. The appointment strengthens Cyclic Materials’ executive team as the company accelerates commercial expansion across North America, Europe, and Asia. Most recently, Poznar served as Chief Commercial Officer at Ascend Elements, where he led the company’s global commercial strategy, strategic partnerships, and business development. During his tenure, he helped secure more than USD $1.5 billion in commercial agreements, including a landmark USD $1 billion supply agreement with a major global automaker, while also supporting approximately USD $320 million in TCTF government funding that accelerated the company’s growth in North America and Europe. Prior to Ascend Elements, Poznar held leadership and engineering positions at A123 Systems, EnerDel, Delco Remy, and Volvo, where h
Modon Holding and Nammos Hotels & Resorts Bring Nammos Ras El Hekma to Egypt’s North Coast16.7.2026 15:50:00 EEST | Press release
Abu Dhabi-based Modon Holding and Nammos Hotels & Resorts have announced Nammos Ras El Hekma – the renowned lifestyle and hospitality brand’s first fully integrated destination in Egypt. Located within the Wadi Yemm precinct, the development will bring Ras El Hekma’s promise of timeless Mediterranean living to life, combining Nammos Residences, Nammos Resort, Nammos Village, and a curated selection of all-day dining and wellness experiences, including the globally renowned Nammos Restaurant & Beach Club. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716740934/en/ Modon Holding and Nammos Hotels & Resorts bring Nammos Ras El Hekma to Egypt’s North Coast (Photo: AETOSWire) Nammos Ras El Hekma represents a new expression of contemporary Mediterranean luxury. Reflecting both the natural beauty of Egypt’s North Coast and the refined yet vibrant lifestyle associated with Nammos, the destination introduces a lifestyle concept i
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