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
Ares Strengthens Commitment to Plenitude Through €1 Billion Capital Contribution1.10.2026 09:30:00 EEST | Press release
Ares Management Corporation (NYSE: ARES), a leading global investment manager, announced today that Ares Alternative Credit funds (“Ares”) participated in a reorganization of the shareholding and governance structure of Plenitude through which Ares and Eni S.p.A (“Eni”) upsized their capital contribution by approximately €1.5 billion, of which over €1 billion is attributable to Ares, based on a pre-money equity valuation of Plenitude of €10.75 billion. Following completion of the transaction, Ares holds 26.24% of Plenitude’s share capital, with Eni holding 65.03% and Energy Infrastructure Partners (“EIP”) as an 8.73% shareholder. Ares first invested in Plenitude in 2025, acquiring a 20% stake in the business for approximately €2 billion. This transaction is geared towards strengthening Plenitude’s capital structure and introduces an enhanced governance framework that supports the company’s long-term growth ambitions. Ares and Eni will jointly control Plenitude, with Ares appointing thr
Orifarm Unveils 2031 Strategy to Accelerate Growth Across Europe, With Significant Expansion in Generics1.10.2026 09:10:00 EEST | Press release
With its five-year strategy, Fit to Scale, Orifarm sets out an ambitious path to scale across Europe, including a major expansion of its prescription medicines business from a Nordic footprint to a broader European platform. The strategy aims to double EBITDA to €300m and generate more than €3bn in revenue by 2031, marking the next step in Orifarm's journey as a diversified European pharmaceutical company bringing affordable medicines to more customers, patients and healthcare systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930257993/en/ Orifarm Headquarter, Odense Denmark “As European healthcare systems face rising demand, budget pressures, and supply challenges, Orifarm is uniquely positioned to improve access to affordable medicines and strengthen European supply. Our Fit to Scale strategy is about playing an even bigger role in meeting these needs and taking Orifarm to the next level,” says Mads Fink Eriksen,
Thales Launches Sentinel Envelope Plus to Protect Software Against AI-Assisted Reverse Engineering1.10.2026 09:01:00 EEST | Press release
Thales, a global leader in advanced technologies, today announced Sentinel Envelope Plus, a new addition to its Sentinel Envelope software protection solution that significantly hardens compiled applications against AI-assisted reverse engineering, automated zero-day vulnerability discovery, and automated exploit generation. Sentinel Envelope Plus applies multiple layers of protection to software applications, without requiring source code changes or any special compilation environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930063281/en/ AI-assisted tools are making it faster and easier to analyze software for vulnerabilities, reducing the specialist expertise and time traditionally required for reverse engineering. This creates new risks for software vendors, particularly when applications are deployed outside environments they control. On-premises, embedded and edge devices are at increased risk, as attackers
Thales Strengthens Data Security Posture Management to Address Emerging Risks of AI1.10.2026 09:00:00 EEST | Press release
Thales, a global leader in advanced technologies for cybersecurity markets, today announced CipherTrust Data Security Posture Management (DSPM). It is the first purpose-built DSPM offering designed to help organizations go beyond discovering exposed sensitive data and applying access-based remediation, enabling them to prioritize risks and protect their most sensitive data directly through encryption, masking, or tokenization natively within the platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930800339/en/ Sensitive data is increasingly distributed across cloud infrastructure, SaaS applications, on-premises systems, analytics environments and third parties. AI is accelerating the challenge as copilots, applications and agents gain access to enterprise data and information moves into new repositories and workflows much faster than traditional governance can keep pace. Security teams need to understand more than ju
NHOA Energy Achieves UNI/PdR 125:2022 Gender Equality Certification1.10.2026 09:00:00 EEST | Press release
NHOA Energy, global provider of utility-scale energy storage systems, has obtained the UNI/PdR 125:2022 Gender Equality Certification for its Gender Equality Management System in Italy. Issued by RINA following an independent audit, the certification evaluates the Company’s approach to gender equality through qualitative and quantitative indicators across six key areas: recruitment and hiring, career management, pay equity, parenting and caregiving, work-life balance, and the prevention of workplace abuse and harassment. “Building a strong company also means creating an environment where people have equal opportunities to contribute, grow and lead. This certification is an important recognition of the work already done, but above all a commitment to continue improving the way we support our People and strengthen our culture,” said Anita Maria Ganassali, VP Human Capital of NHOA Energy. The certification was celebrated during Winning Women Institute’s event in Milan on 29 September, whe
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