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
FlightSafety International Receives FAA Approval for Virtual Aircraft Preflight Inspection with Evaluation Mode6.5.2026 17:05:00 EEST | Press release
FlightSafety International Inc., the global leader in aviation training and simulation technology, today announced it has received Federal Aviation Administration (FAA) approval for Virtual Aircraft Preflight Inspection (VAPI) with Evaluation Mode for three aircraft training programs: the Embraer EMB-550, Gulfstream G500/G600, and Citation Latitude. This innovative capability allows pilots in initial training to complete a 3D virtual aircraft preflight inspection while in Training Mode, with the added ability to transition directly into the flight deck, followed by Evaluation Mode, that allows pilots to do their preflight check ride portion. “VAPI represents a meaningful advancement in training innovation,” said David Penney, VP of Safety, Courseware and Regulatory Affairs, FlightSafety International. “By leveraging an immersive 3D environment, it offers pilots a more engaging and practical way to develop aircraft familiarity, strengthen inspection discipline, and better prepare for re
Riskified Unveils Next-Generation AI Suite at Ascend 2026, Empowering Merchants with Unprecedented Visibility and Control Over Ecommerce Risk6.5.2026 16:00:00 EEST | Press release
Riskified (NYSE: RSKD), a global leader in ecommerce fraud and risk intelligence, today announced a major leap forward in its AI platform capabilities, introducing a powerful suite of control and empowerment tools designed to give merchant fraud teams complete visibility into risk patterns and identity behavior, conversational AI-driven insights, and the ability to surgically tailor their risk strategies. The innovation suite was announced onstage at Ascend 2026, Riskified’s premier global summit series, taking place May 4-6, 2026, at the Conrad New York Downtown in Manhattan, NY. With global ecommerce continuing to expand and losses from AI-driven fraud attacks projected to spike, particularly with the rise of agentic commerce, where AI bots may conduct transactions on behalf of consumers, accurate fraud decisions are fundamental, but are no longer enough. Today, more than ever, sophisticated fraud and risk teams need to understand the why behind every transaction and pattern, and req
Twilio’s Next Generation Platform: An Infrastructure Layer for Every Conversation in the Agentic Era6.5.2026 16:00:00 EEST | Press release
Twilio (NYSE: TWLO), the infrastructure for customer engagement in the AI era, kicked off its user conference, SIGNAL, by unveiling its next generation platform capabilities for the agentic era. Generally available today, Conversation Memory, Conversation Orchestrator, Conversation Intelligence, and Agent Connect combine to turn disparate interactions into continuous, intelligent, and personal conversations across humans, agents, and systems. “The agentic era is here. Agents are joining conversations alongside the people they represent, and modern customer engagement requires an infrastructure that serves both equally,” said Khozema Shipchandler, Chief Executive Officer at Twilio. “Twilio’s new platform is the foundational infrastructure layer that makes every conversation persistent, contextual, and actionable – ensuring interactions feel like part of one continuous relationship." An Infrastructure Layer for Every Conversation Every business runs on conversations. Today, however, busi
Vultr, SUSE & Supermicro Debut Unified Cloud-to-Edge Architecture for Global AI Scaling6.5.2026 15:00:00 EEST | Press release
Vultr, the world's largest privately-held cloud infrastructure company, in collaboration with SUSE and Supermicro, today announces a strategic architectural framework designed to solve the complexities of deploying and operating AI workloads across distributed environments. As AI moves closer to the point of data creation - from manufacturing floors to retail storefronts - organizations face significant challenges in latency, cost and operational consistency. This joint initiative provides a seamless, Cloud-to-Edge pipeline that integrates high-performance hardware, localized cloud infrastructure, and unified Kubernetes management. The partnership addresses the reality that sending all data back to a central cloud is no longer viable for real-time AI. The solution breaks down the infrastructure into three critical layers: The Cloud and Near-Edge - Enterprises can deploy regional Kubernetes-based AI clusters closer to their users by leveraging Vultr’s 33 global cloud data center regions
Waiv Enters Collaboration with Daiichi Sankyo to Deliver AI-Derived Biomarkers for ADC Program6.5.2026 15:00:00 EEST | Press release
Waiv, formerly Owkin Dx, a Paris-based company catalyzing AI precision testing, today announced it has entered a collaboration with Daiichi Sankyo (TSE: 4568) to lead digital pathology biomarker discovery for an antibody-drug conjugate (ADC) program. With deep expertise across diverse pathology and multimodal data, and a global data network spanning academic institutions, hospitals, and laboratories, Waiv has a proven track record delivering AI-powered biomarker solutions across the full drug development lifecycle. Under the collaboration, Waiv will apply its end-to-end computational pathology platform to early phase data. This includes tumor microenvironment (TME) analysis across both hematoxylin and eosin (H&E) and immunohistochemistry (IHC) stained samples, as well as biomarker discovery and outcome prediction capabilities aimed at identifying biomarkers of treatment response ahead of next clinical trial phases. Purpose-built AI approach tackles one of pharma's hardest challenges: b
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