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
TOURISE and Oxford Economics Release New Global Report on Tourism Resilience in an Era of Permanent Disruption17.8.2026 17:33:00 EEST | Press release
TOURISE, in collaboration with Oxford Economics, today released a new report, “Resilience in a World that Doesn’t Reset: Redesigning Tourism for an Era of Permanent Disruption.” The analysis of 85 major crises over two decades shows a clear pattern: in a world defined by continuous shocks, destinations that act before disruption hits recover up to 1.5 times faster than those that wait. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260817880835/en/ “In a world that does not reset between crises, disruption is a constant feature of the global tourism landscape,” said His Excellency Ahmed Al-Khateeb, Minister of Tourism of Saudi Arabia and Chairman of TOURISE. “The real test for destinations measures how they prepare for volatility, protect traveler confidence, and maintain continuity ahead of such events.” Using the current Middle East crisis as a lens, where Gulf hubs carry roughly 14 percent of global transit traffic, the r
The Expensify Visa® Commercial Card Brings New Proactive Spend Controls to 14 Countries17.8.2026 16:00:00 EEST | Press release
Expensify, Inc. (Nasdaq: EXFY), the easiest way to manage expenses, travel, and corporate cards, today expanded the reach of Expensify Card spend rules, the market-leading way for businesses to control corporate card spend before it happens. Available to businesses in 14 countries, spend rules let admins decide exactly how, where, and when each Expensify Card can be used, so only compliant transactions go through. Unlike traditional corporate cards that rely on after-the-fact expense review, the Expensify Card enforces policy at the point of purchase. Admins set the rules once, and the card handles the rest. With Expensify Card spend rules, admins can: Lock a card to a subscription. Give each recurring SaaS tool its own virtual card, so a vendor can only ever charge what it should. If the card owner changes teams or leaves, the subscription keeps running, with no swapping cards and no missed payments. Cover a one-time purchase. Issue a virtual card for a single transaction like event r
Riskified Analysis Finds Travel Fraudsters Are Adapting Faster Than Traditional Signals Can Keep Up, With May Flight Risk Up 32%17.8.2026 15:30:00 EEST | Press release
Riskified (NYSE: RSKD), a global leader in ecommerce fraud and risk intelligence, today released new findings from its Travel Industry Insights report, revealing how sophisticated fraud rings and AI-enabled fraudsters are evolving their tactics across airlines, hotels, and online travel platforms. Riskified’s analysis shows that fraudsters are increasingly adapting their behavior to resemble legitimate travelers, making traditional fraud indicators less reliable and creating new challenges for travel merchants. Riskified’s analysis of hundreds of millions of travel transactions across flights, hotels, and land transportation found that flight fraud risk increased through the first five months of 2026, with May 2026 marking the sharpest year-over-year increase at 32% compared to May 2025. The findings show that sophisticated fraud activity is not limited to predictable travel peaks, with organized fraud rings continuously adjusting their methods throughout the year. Riskified's travel n
PIF Delivers Strong Revenue and Profit Growth in 202517.8.2026 14:54:00 EEST | Press release
PIF today published its 2025 Annual Report demonstrating strong financial performance and continued progress against its long-term objectives. As a long-term investor with a unique mandate to drive the economic transformation of Saudi Arabia and deliver sustainable financial returns, PIF maintained a diversified portfolio in 2025, balancing returns with national impact and long-term resilience. Maintaining Financial Discipline In 2025, revenue rose 9% year on year to $120 billion, while net profit more than doubled to $17 billion, supported by stronger contributions from maturing portfolio companies. PIF retained over $900 billion in assets under management and achieved an annualized total shareholder return of 5.8% since 2017. Total shareholder return in 2025 was positively driven by increased dividends from portfolio companies and returns from financial investments. It was also impacted by downward movements in the valuations of some assets, as a result of wider market conditions, an
Foundever Successfully Closes a Holistic Recapitalization, Reducing its Debt by Nearly $900 Million and Strengthening its Financial Position for Long-Term Growth17.8.2026 14:30:00 EEST | Press release
Foundever Group S.A.® (“Foundever” or the “Company”) – a global leader in integrated customer experience, digital operations and analytics services, today announced that it has successfully closed a holistic recapitalization (the “Transaction”) in coordination with 95.4% of the lenders under its term loan facility (“Term Loan Lenders”), 100% of its revolving credit facility lenders (“RCF Lenders”), and the Company’s existing majority shareholders. The Transaction meaningfully strengthens Foundever’s financial foundation and positions the Company to invest in its growth strategy. Key terms of the Transaction include: Company's existing majority shareholders invest $225 million into common equity. Term loan facility exchange reduces the Company's total debt by nearly $900 million. Revolving credit facility maturity date is extended by more than four years to December 2030, and term loan maturity date is extended by more than 2.5 years to March 2031. Certain of the Company's RCF Lenders p
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