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
ClickHouse Launches ClickHouse Labs With Andy Pavlo as VP of Database Research3.8.2026 16:30:00 EEST | Press release
ClickHouse today announced the launch of ClickHouse Labs, a new research group led by Andy Pavlo, one of the database industry’s most prominent researchers. Dr. Pavlo joins ClickHouse as Vice President of Database Research and will build a team dedicated to advancing the state of the art in database systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260803890510/en/ Andy Pavlo, VP of Database Research, ClickHouse Pavlo is an award-winning database researcher and professor at Carnegie Mellon University’s Computer Science Department. He is known throughout the database community for his work on autonomous databases, transaction processing, and large-scale data analytics. At ClickHouse, he will bring that expertise to some of the most ambitious and consequential challenges facing modern data systems, as AI reshapes the demands placed on all data-intensive workloads. “At ClickHouse, we are interested in finding new and inno
Lehman Brothers Treasury Considers Sale and Final Wind-Down3.8.2026 16:30:00 EEST | Press release
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Herbert Smith Freehills Kramer (USA) LLP, announced that LBT is considering a final wind-down of its estate. In connection therewith, LBT has retained Seaport Loan Products LLC as its exclusive placement agent in connection with the potential sale of LBT’s principal remaining asset – a $19.6 billion Class 4A allowed claim against Lehman Brothers Holdings Inc. (the “LBHI Claim”). LBT expects the sale to occur, if at all, in August 2026. To the extent the LBHI Claim is sold, LBT expects to make a final distribution to the holders of its existing notes and thereafter facilitate the cancellation of those notes and the final wind down of its estate in September 2026. The foregoing is subject to further consents and authorizations and LBT retains sole discretion to abandon or otherwise discontinue any sale process at any time. Accordingly, there can be no assurances that the sale process will be conducte
EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership3.8.2026 16:00:00 EEST | Press release
EuroTeleSites, one of Central and Eastern Europe's leading independent tower companies, today announced the results of its first year in partnership with Sitetracker, the leading global Asset Lifecycle Management platform. One year into the deployment, EuroTeleSites reports meaningful progress in its digital transformation, with measurable improvements in operational efficiency, cross-market transparency, and project coordination across its six-country footprint. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727009809/en/ EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership Driving Efficiency in a Complex, High-Investment Environment EuroTeleSites invests approximately 25% of its revenue into capital expenditures in 2026, funding the construction and upgrade of tower infrastructure across Central and Eastern European markets. Managing this level of scale and complexity demands robust digital support
Visa to Acquire BioCatch3.8.2026 15:30:00 EEST | Press release
Visa (NYSE: V) today announced it has signed a definitive agreement to acquire BioCatch, a leading provider of behavioral-first, multi-signal fraud intelligence, from funds advised by Permira and other shareholders for $2.4 billion in cash. The acquisition of BioCatch complements Visa’s existing cyber, fraud, risk and security solutions and is expected to help clients better protect themselves and their customers from the growing threat of account takeovers, scams, money mules and application fraud. Since its inception, BioCatch has developed innovative AI and machine learning-based solutions that analyze thousands of application, behavioral, device, and network signals—such as keystrokes, touch gestures, and device handling—to detect fraud and distinguish legitimate users from fraudsters in real time. BioCatch protects 1.8 billion devices and 760 million users around the world, serving more than 350 banking clients in 21 different countries, including more than 100 of the largest bank
U.S. Bank Investment Services enhances investor and client onboarding experience for alternative investments3.8.2026 15:16:00 EEST | Press release
U.S. Bank Investment Services today announced it has gone live with a new client lifecycle management (CLM) platform, providing a comprehensive onboarding solution for alternative investment clients and the investors in their funds. The implementation is a key milestone in Investment Services’ multi-phased technology transformation strategy, aimed at modernizing processes, workflows and reporting across the private funds space. U.S. Bank leverages CLM provider Fenergo and its Fen-X platform. Fen-X automates many of the manual processes traditionally associated with underlying investors and direct client relationships and accelerates account setup while maintaining regulatory requirements. The enhanced onboarding experience provides investors and clients with more transparency throughout the process and enables integration with other solutions providers involved in the investor journey, such as screening and tax reporting. The investor experience has been further enhanced with an invest
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