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
Pure Lithium Announces Unprecedented Cycling Results From Its Advanced Anode™ Lithium Metal Battery Technology26.8.2026 14:00:00 EEST | Press release
Pure Lithium Corporation, a vertically integrated lithium metal battery technology company, today announced that our Advanced Anode™ battery, technology developed specifically to enable ultra-long cycling, has achieved more than 9,315 cycles. The cells continue to cycle in the Company's laboratory. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260826201214/en/ To the Company’s knowledge, no other lithium metal battery in development has achieved such results under equivalent testing conditions. The performance of the Company’s battery, achieved with negligible capacity fade, far exceeds today’s commercial lithium-ion battery cycling requirements across numerous applications, where performance typically ranges from 250 to 2,000 cycles, depending on the application. These results were achieved at 100% depth of discharge, and charge rates of 1C: 1C.1 “The results of Pure Lithium’s cycling performance are disruptive. Cycle life
Infopro Digital Automotive Highlights Its Industry-Leading Datasets at Automechanika 202626.8.2026 11:02:00 EEST | Press release
Infopro Digital Automotive, leader in data and software for the automotive market, announces its participation in Automechanika 2026, the world’s leading trade fair for the automotive industry. After completing several significant acquisitions over the past years, including Eucon, GiPA, and Aurelis last September, the company will attend this year’s trade show with a consolidated offering, built upon its trusted industry-leading datasets. Infopro Digital Automotive now addresses every automotive vertical from independent workshops to parts, tyres and car manufacturers, through the whole network of aftermarket distribution professionals, thus delivering to them key data and integrated digital solutions to power strategic decisions at every step of the vehicle lifecycle. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260826133342/en/ Infopro Digital Automotive’s unmatched dataset portfolio will be presented at Automechanika 20
NIPPON KINZOKU Establishes Mass Production of Ultra-Thin and Narrow Stainless Steel for Insulin Needles26.8.2026 11:01:00 EEST | Press release
NIPPON KINZOKU CO., LTD. (Headquarters: Minato-ku, Tokyo; President: Yasushi Shimokawa; TOKYO: 5491) is pleased to announce the commencement of mass production for its "Ultra-thin and narrow-width stainless steel" optimized for laser welding in ultra-fine insulin needles. In response to growing global demand, the company has established a stable supply system for these high-quality materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260826770424/en/ The scale of the global diabetes crisis is expanding. In line with this trend, the global demand for insulin needles continues to escalate. Furthermore, insulin delivery is evolving toward "painless" experiences that reduce patient burden. Modern designs prioritize minimizing pain and bruising, leading to the widespread adoption of ultra-fine needles. This trend is further supported by the growing popularity of compact, portable pen injectors. Additionally, the global rise
VirTus Respiratory Research Supports Development of Apollo Therapeutics’ APL-10456 from Preclinical Proof of Concept to Positive Phase 1 Data26.8.2026 11:00:00 EEST | Press release
VirTus Respiratory Research Ltd, a specialist respiratory contract research organisation (CRO), founded by Imperial College London investigators Professor Sebastian Johnston and Dr Michael Edwards, today highlighted its role in the preclinical development of Apollo Therapeutics’ and Imperial’s APL-10456, following the announcement of positive initial data from the vaccine’s Phase 1 clinical trial. VirTus has worked on the APL-10456 programme for more than five years, conducting more than 20 preclinical studies to support the selection, development and progression of the candidate, testing the cross-species immunogenicity and efficacy. This work included evaluating the efficacy of several vaccine candidates in mouse models of rhinovirus infection, helping to select APL-10456 and establish early proof of concept and generating preclinical evidence that informed its progression into first-in-human clinical development. APL-10456 is a first-in-class, adjuvanted recombinant protein subunit
Xsolla President Chris Hewish Debuts “Durable Advantage” at Gamescom 202626.8.2026 10:00:00 EEST | Press release
Xsolla, a leading global commerce company, today announced Durable Advantage: Five Pillars of the Modern Game Business, a new book authored by Chris Hewish, President of Xsolla, launching at Gamescom 2026 in Cologne. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260826628682/en/ Graphic: Xsolla Xsolla's integrated strategy brings together global payments, direct-to-consumer commerce, backend infrastructure, and AI-powered development tools into a unified operating model designed to help studios launch, operate, and scale more efficiently. Rather than relying on disconnected commerce, engagement, and backend systems, developers can activate new capabilities through a common platform foundation that reduces complexity, accelerates deployment, and creates a more durable foundation for long-term growth. The strategic framework behind this vision is outlined in Durable Advantage. "There are two kinds of game companies, renters a
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