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
Nexo Reaffirms EU Compliance28.7.2026 17:00:00 EEST | Press release
Nexo, a leading digital assets wealth platform, today reaffirmed product compliance across the European Economic Area (EEA), achieved ahead of MiCAR’s entry into force. The company operates with a local setup through two MiCAR-licensed partners bringing technical depth and operational maturity to Nexo's client-facing platform in the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260728038475/en/ Nexo's setup pairs its global wealth platform with dedicated, licensed European infrastructure — splitting custody and brokerage across two regulated partners: Tangany, licensed under MiCAR, provides institutional-grade custody infrastructure for digital assets. Meanwhile, DLT Finance, licensed under MiCAR and authorized under MiFID II, provides brokerage infrastructure for digital assets and financial instruments. Together, these partnerships pair Nexo’s global wealth platform with infrastructure specifically built for Europ
Interactive Brokers Opens AI Connectivity to Any Tool Built on the MCP Standard28.7.2026 17:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced that clients can now connect their accounts to nearly any AI tool they already use. Previously limited to the certified marketplaces for ChatGPT, Claude, and Grok, clients can now also connect from a growing range of tools that support the Model Context Protocol (MCP), including Claude Code, Cursor, Perplexity, and Windsurf. MCP has become the common standard for connecting AI applications to outside services. Interactive Brokers' AI Integration has been built on MCP since launch, and clients can now connect from any MCP-compatible tool in addition to the certified marketplaces. “Interactive Brokers has long offered open APIs that let clients connect their accounts to the tools and systems they choose,” said Milan Galik, Chief Executive Officer of Interactive Brokers. “Supporting AI tools built on the Model Context Protocol (MCP) is a natural extension of that philosophy. It gives clients the flexibility to
Estée Lauder Announces New Fragrance, Glimmer, with Global Campaign Starring Hailee Steinfeld28.7.2026 17:00:00 EEST | Press release
Today, Estée Lauder announces the launch of Glimmer, a new prestige fragrance created for a new generation of consumers. An amber floral fragrance with a gourmand twist, Glimmer transforms the power of everyday "glimmers” - small moments of joy, hope, and connection - into a sensorial fragrance experience designed to inspire optimism, foster community, and leave a lasting impression. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727469772/en/ Hailee Steinfeld stars as the face of Glimmer Acclaimed actress and singer Hailee Steinfeld stars as the face of Glimmer. Rooted in the belief that one spark can ignite many, the campaign positions Hailee and her singing voice as catalysts for the joy, optimism, and connection that are at the heart of Glimmer. “Hailee is the embodiment of what Glimmer represents; she is confident, has a contagious sense of joy, and understands the power of connecting with her community,” said Justin
Mindbreeze InSpire Reduces Token Maxxing, Turning Runaway AI Costs Into Predictable Enterprise Value28.7.2026 16:03:00 EEST | Press release
Mindbreeze, a leading global provider of AI-based knowledge management solutions, today announced that Mindbreeze InSpire reduces token maxxing, the costly overconsumption of large language model (LLM) tokens that is straining enterprise AI budgets. By retrieving only the most relevant, grounded content and passing it to LLMs with precision, Mindbreeze InSpire lowers the tokens required per answer while improving accuracy, giving enterprises a path to scalable AI with predictable economics. Token maxxing has become one of the most underestimated risks in enterprise AI. As organizations connect generative AI to their data, many default to injecting large volumes of undifferentiated context into every prompt, repeatedly, across thousands of queries. Industry analysis has warned that tokens are becoming the true unit of AI cost, with usage-driven and nonlinear spending that is difficult to forecast and quick to erode margins. The problem is rarely the model. It is what the model is asked
Uptime Institute 16 th Annual 2026 Global Data Center Survey: Deployment of High Density Racks Rising Fast, Operators Face Continued Recruiting and Retention Pressures28.7.2026 16:02:00 EEST | Press release
Uptime Institute today released the findings of its 16th Annual Global Data Center Survey, the most comprehensive study of the digital infrastructure sector. The 2026 results reveal an industry navigating workforce constraints, escalating outage expenses, even as rising costs remain the top concern for management teams. Financial Pressure and Resource Constraints Intensify: While high costs continue to be a primary concern for data center leaders, the 2026 survey also highlights escalating concerns over capacity forecasting, power availability, and supply chain disruptions. Power efficiency gains remain gradual. The industry saw minor improvements in average Power Usage Effectiveness (PUE) levels this year. While newer facilities may boast highly efficient designs, overall global progress is slowed by legacy infrastructure. The AI and Density Reality Check: Despite market enthusiasm for Artificial Intelligence, expectations for AI in data center operations cooled slightly in 2026. Oper
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