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
Grid Dynamics Launches Business Process Consulting Practice to Bridge the Gap Between AI Investment and Business Results27.10.2026 22:05:00 EET | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, today announced the launch of its Business Process Consulting practice, extending the company's AI transformation capabilities across the entire AI adoption lifecycle, beyond technology implementation to non-technical areas of enterprise AI value creation. Grid Dynamics has established itself as a leader in enterprise AI engineering, developing and deploying advanced AI solutions for some of the world's largest enterprises. Drawing on this experience, the company is expanding its focus to two critical factors in maximizing the business impact of AI: identifying the business domains and processes with the greatest potential for AI-driven improvement, and ensuring that the resulting solutions are successfully adopted across the enterprise. Starting with early discovery, the practice identifies and prioritizes high-value transformation opportunities, establishes busines
Logitech Announces Q2 Fiscal Year 2027 Results27.10.2026 22:05:00 EET | Press release
SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the second quarter of Fiscal Year 2027. Sales were $1.22 billion, up 3 percent in US dollars and 2 percent in constant currency, compared to Q2 of the prior year. GAAP gross margin was 44.9 percent, up 150 basis points compared to Q2 of the prior year. Non-GAAP gross margin was 45.2 percent, up 140 basis points compared to Q2 of the prior year. GAAP operating income was $201 million, up 5 percent compared to Q2 of the prior year. Non-GAAP operating income was $231 million, up 0.4 percent compared to Q2 of the prior year. GAAP earnings per share (EPS) was $1.25, up 9 percent compared to Q2 of the prior year. Non-GAAP EPS was $1.51, up 4 percent compared to Q2 of the prior year. Cash flow from operations was $164 million. The quarter-ending cash balance was $1.51 billion. The Company returned $406 million of cash to shareholders in the qu
Hightouch Partners with Independent Media to Activate Reader and Commercial Data27.10.2026 18:01:00 EET | Press release
Hightouch, the leading agentic marketing platform, today announced a partnership with Independent Media, publisher of The Independent. Independent Media will use Hightouch to connect its customer data to marketing tools. With Hightouch, the company will send readers more relevant membership and subscription offers, build stronger audiences for its advertising partners, and grow its affiliate and e-commerce business. “Deepening customer relationships and delivering real value to our commercial partners requires moving seamlessly from insight to action,” said Krishan Gandhi, Director of Data Intelligence and Monetisation at Independent Media. “Partnering with Hightouch allows us to utilise our warehouse data directly into our engagement tools, powering real-time, omnichannel journey orchestration, while enabling us to build premium audience segments with far greater speed and agility.” “Independent Media has a large, loyal readership and strong relationships with advertisers,” said Matth
IFF Identifies Ten Consumer Moments Reshaping Food and Beverage Innovation in the GLP-1 Era27.10.2026 17:00:00 EET | Press release
IFF (NYSE: IFF)—a global leader in flavors, fragrances and health and biosciences, today launched its latest report, “GLP-1 Consumer Moments of Opportunity.” The report uncovers ten emerging consumer moments that reflect the changing needs of consumers using GLP-1 medications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026614988/en/ New report from IFF uncovers ten emerging consumer moments that reflect the changing needs of consumers using GLP-1 medications. “What GLP-1 users need from food and beverage products depends on the moment, and those needs can change many times throughout the day,” said Yuvraj Arora, president of IFF Taste. “The most successful innovations will be designed around the occasions that matter most to consumers, delivering the right balance of nutrition, enjoyment and functionality for each one. Understanding these moments can unlock entirely new avenues for innovation." While much of the indus
Phison Receives Micron Global Supplier Awards27.10.2026 16:00:00 EET | Press release
Phison Electronics (8299TT), a global leader in NAND flash controllers and storage solutions, is honored to announce that it was presented with Outstanding Supplier Performance Awards in the Semiconductor category and the Best in Quality – Assembly and Test categoryat the Micron Supplier Day 2026. The event, held in Boise, Idaho, United States was attended by top-level management of Micron and its suppliers, including Phison. The awards highlight our commitment to excellence in quality, innovation and collaboration with Micron, a global leader in semiconductor memory and storage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027158504/en/ Phison wins Outstanding Supplier Performance Award in Semiconductor category and the Best in Quality – Assembly and Test category at the Micron Supplier Day 2026 “Receiving our third Micron Supplier Award in a row is a tremendous honor and a testament to the strength of our partnership
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