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
LTM Launches BlueVerse™ for iRun to Outcreate Managed Services in the Agentic AI Era15.6.2026 09:10:00 EEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, today announced the launch of BlueVerse™ for iRun, an AI-native managed services model designed to transform traditional IT operations into a resilient, intelligent, and outcome-driven operating model. As enterprise environments grow more complex—spanning hybrid cloud, SaaS, and AI-driven ecosystems—traditional managed services models are increasingly constrained by siloed teams, static processes, and effort-led scaling. BlueVerse for iRun addresses this shift by moving beyond headcount-based delivery to a platform-led approach powered by agentic AI, knowledge convergence, and process-as-code. Built on the BlueVerse ecosystem, iRun creates a unified intelligence layer that brings together enterprise data, telemetry, workflows, and operational context—enabling AI to reason across systems, identify root causes, and execute actions within governed guardrails. iRun combines AI agents and human expertise to shift opera
Azafaros to Present at BIO International Convention 202615.6.2026 08:00:00 EEST | Press release
Azafaros, a private company building a portfolio to become a leader in lysosomal storage disorders (LSDs), focused on addressing neurological symptoms, today announced that it will present at the 2026 BIO International Convention taking place in San Diego, USA, from June 22-25. The company’s presentation is scheduled for Monday, June 22 at 4:30 PM in Theater 4. The presentation will highlight Azafaros’ progress in developing nizubaglustat, its lead investigational compound for the treatment of rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses (GM1/GM2) and Niemann-Pick type C disease (NPC). Nizubaglustat is currently in two Phase 3 registrational studies (NAVIGATE) treating patients with GM1/GM2 and NPC and expects to report topline data from the studies in 2028. “BIO provides an important opportunity to update our progress as we continue advancing nizubaglustat through late-stage clinical development,” said Stefano Portolano, CEO at A
Teledyne FLIR Defense Launches Black Recon™ Autonomous Micro-Drone15.6.2026 07:05:00 EEST | Press release
Teledyne FLIR Defense, part of Teledyne Technologies Incorporated (NYSE: TDY), today announced at Eurosatory the market launch of Black Recon™, an autonomously launched micro-drone system that delivers continuous, untethered reconnaissance from military vehicles and fixed installations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260614388428/en/ Teledyne FLIR Defense announced at Eurosatory the market launch of Black Recon™, an autonomously launched micro-drone that delivers continuous, untethered reconnaissance from military vehicles and fixed installations. Black Recon allows crews to launch, operate, recover, and recharge up to three UAS without leaving their platform, reducing operator risk. Designed for vehicle integration, Black Recon allows crews to launch, operate, recover, and recharge up to three unmanned aerial systems without leaving their platform, reducing risk and accelerating decision-making. “Black Recon
OM Pharma to Unveil the Largest Multi-Country Real-World Evidence Study on Broncho‑Vaxom® (OM‑85) for RTI Prevention at EAACI 202614.6.2026 11:00:00 EEST | Press release
OM Pharma will reveal preliminary results from the REACH study at the European Academy of Allergy and Clinical Immunology (EAACI) Congress. REACH is the first and largest multi-country real-world evidence (RWE) study to date evaluating the impact of Broncho-Vaxom® in patients with recurrent respiratory tract infections (RTIs).1,2 The findings offer critical new clinical evidence of the therapy's effectiveness in everyday clinical practice. In a real-world cohort of 15,794 paediatric (aged >1 year), adolescent, adult and elderly patients in China, Italy, and Belgium, Broncho-Vaxom® was associated with reductions in RTI recurrence and healthcare utilisation at 12 and 24 months after treatment initiation, compared with the 12 months prior to starting the therapy.1 “The REACH real-world evidence study shows that Broncho-Vaxom® can significantly reduce infections requiring medical visits across age groups and co-morbidities,” said Anna Thomas, Chief Scientific Officer at OM Pharma. “Recurre
Incyte Announces New Positive Data at EHA 2026 Showed INCA033989 Achieved Rapid, Robust and Sustained Clinical and Molecular Responses and Was Well Tolerated in Patients with Myelofibrosis and Essential Thrombocythemia13.6.2026 18:15:00 EEST | Press release
Incyte (Nasdaq:INCY) today announced updated clinical data from two Phase 1 studies evaluating the safety, tolerability and efficacy of INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). INCA033989 demonstrated rapid, clinically meaningful responses and consistent molecular activity across both myelofibrosis (MF) and essential thrombocythemia (ET), with convergent evidence supporting the potential for disease modification. These findings are being presented in oral and poster presentations at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden (Session: Myeloproliferative neoplasms – Clinical, Presentation numbers: S216, PS1983, PF884). “The data presented at EHA 2026 demonstrate clinically meaningful and consistent responses with INCA033989 across both myelofibrosis and essential thrombocythemia,” said Pablo J. Cagnoni, M.D., President of Incyte and G
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