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
MSCI Announces the Results of the MSCI 2026 Market Classification Review24.6.2026 00:42:00 EEST | Press release
MSCI released the results of the MSCI 2026 Market Classification Review. Key takeaways from this year's review include: Reclassification of Bulgaria from Standalone to Frontier Market status Assessment of shareholder transparency and coordinated trading concerns in the Indonesian and Turkish equity markets, acknowledging the announced steps undertaken by both markets to address these matters and noting the continued potential for future consultations on the appropriate treatment of these markets if credible progress is not observed Acknowledgement of the removal of floor prices in Bangladesh, with a caution that any reintroduction could prompt a consultation on reclassification from Frontier to Standalone Market status Ongoing monitoring of the implementation of measures aimed at improving the accessibility of the Korean equity market for international institutional investors Reminder on the reclassification of Greece from Emerging to Developed Market status at the May 2027 Index Revie
Elliptic Intelligence Used by the FBI in Action Against Huione, the $134 Billion Criminal Marketplace and Money Laundering Operation24.6.2026 00:28:00 EEST | Press release
Elliptic, the global leader in digital asset decisioning, today announced that its intelligence was used by the Federal Bureau of Investigation in today's action against the operators of Huione Group. The Justice Department announced the seizure of a cloud computing account used by subsidiaries of the Huione Group, a Cambodia-based corporate conglomerate. First exposed by Elliptic in July 2024, Huione Guarantee was a Telegram-based marketplace serving online fraudsters across Southeast Asia. Merchants sold money laundering services, stolen personal data, websites and other goods and services necessary to perpetrate so-called “pig-butchering” scams and other online fraud., By the time Huione was forced offline, it had received more than $31 billion in cryptoasset transactions, making it the largest illicit online marketplace ever recorded, more than 25 times larger than Silk Road and AlphaBay combined. Huione Group’s payments arm, Huione Pay, was also implicated in the laundering of pro
Rockwell Automation Site Named a World Economic Forum Global Lighthouse24.6.2026 00:13:00 EEST | Press release
Rockwell Automation, Inc. (NYSE: ROK), the world’s largest company dedicated to industrial automation and digital transformation, today announced its Singapore manufacturing facility has been named a member of the Global Lighthouse Network by the World Economic Forum (WEF). The designation recognizes this facility for applying advanced technologies at scale to deliver measurable improvements in productivity, quality and workforce enablement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623794856/en/ Rockwell Automation Site Named a World Economic Forum Global Lighthouse Rockwell’s Singapore site was recognized with distinction in the productivity category, reflecting its transformation into a highly flexible, data-driven operation. By deploying more than 50 digital and AI-enabled solutions - including intelligent automation, AI-driven quality control and predictive maintenance - the facility improved output efficiency,
NIKE, Inc. Announces Planned CFO Transition23.6.2026 23:17:00 EEST | Press release
NIKE, Inc. (NYSE:NKE) today announced that David M. Denton will join the company as Executive Vice President and Chief Financial Officer, effective August 17. Matthew Friend will step down as Executive Vice President and Chief Financial Officer at that time and remain with the company through September 4 to support an orderly transition. Friend will participate in the company’s fourth quarter fiscal 2026 earnings call on June 30, as planned. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623328558/en/ David M. Denton | Incoming Executive Vice President & Chief Financial Officer, NIKE, Inc. Denton will lead Nike’s global finance organization, partnering with President and Chief Executive Officer Elliott Hill and the Senior Leadership Team to support disciplined execution, capital allocation, and long-term value creation. “Dave is a proven public-company CFO who knows how to help great consumer brands operate with disciplin
Grid Dynamics Hosted XT26, Convening Capital Markets Technology Leaders on the Volatility of AI in Financial Services23.6.2026 23:05:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, hosted XT26. The invite-only conference convened over 250 senior technology leaders from banking, hedge funds, and capital markets at Tower Hill, London. Now in its 10th year, the XT conference series has grown into one of financial services engineering's most respected peer forums in London, built on a single premise: pure thought leadership grounded in real-world experience, with no sales pitches, and no vendor presentations. Just practitioners who are actually doing the work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623112231/en/ Simone Steel speaking at XT26 The event included speakers and delegates from organizations including Bank of America, Citi, HSBC, UBS, RBC, Barclays, JP Morgan, Morgan Stanley, NatWest, Meta, FINOS, and Griffin Bank, among others. With a focus on the volatility of AI i
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