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
David Hagan, Dean and Pegasus Professor at CREOL, The College of Optics and Photonics, Will Serve as Vice President of SPIE26.8.2026 06:00:00 EEST | Press release
David Hagan has been elected to serve as the 2027 Vice President of SPIE, the international society for optics and photonics. He will serve as President-Elect in 2028, and as the Society’s President in 2029. The SPIE Board of Directors is influential in the scientific community, establishing policy and strategy and conducting activities of interest to SPIE Members. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260825934622/en/ Top row, from left to right: David Hagan, Jim McNally, Mark Clampin. Bottom row, from left to right: Marla Dowell, Jana Kainerstorfer, Katie Schwertz The 2026 SPIE President, Julie Bentley, professor of optics at the University of Rochester, made the new electees announcement at the Annual General Meeting of the Society on 25 August during SPIE Optics + Photonics. Terms begin on 1 January 2027. In addition to his work at CREOL (University of Florida, USA), Hagan has been an SPIE Fellow since 2017.His
FORTÉ Acquires Vega Global, APAC's Largest Systems Integrator, Expanding Global Reach26.8.2026 04:00:00 EEST | Press release
FORTÉ, the leader in communication and collaboration solutions designed for the modern workplace, today announced its acquisition of Vega Global, APAC’s largest systems integrator and a leading provider of workplace technology and audiovisual solutions serving corporate, education, government and other market segments. With this acquisition, FORTÉ adds to its international presence, including established office locations in Hong Kong, Mainland China, India, Japan, Taiwan, Thailand, Singapore, Korea, Vietnam, Australia, Philippines, Malaysia, Macau, New Zealand, Indonesia, and United Arab Emirates. With its headquarters in Minneapolis, Minn., FORTÉ also has operations in the U.S., Ireland, Germany, Sweden, the United Kingdom, and Mexico. “Multinational organizations need strategic partners who can deliver consistent communication and collaboration experiences wherever their people work and do business,” said Jeff Stoebner, Chairman and CEO of FORTÉ. “With Vega Global now part of FORTÉ,
Access Advance Launches Exploration Phase for an AV1/AV2 Device and Software Patent Pool, Invites Participation of Potential Licensors26.8.2026 03:00:00 EEST | Press release
Access Advance LLC announced today that in conjunction with the recent release of the AV2 video codec specification, it has launched the exploratory phase for a new patent pool covering devices and software implementing the AV2 video codec, as well as its predecessor AV1. During this exploratory phase, Access Advance will engage with market participants to seek their input, including holding pool formation discussions with potential licensors to gather their feedback on the scope, structure, and terms of a prospective program. All patent owners with a good-faith belief that they own or control AV1 and/or AV2 essential patents are invited to participate in the pool formation discussions. AV1 adoption is being driven largely by members of the Alliance for Open Media (“AOM”). AOM members such as Google, Meta, and Netflix increasingly utilize AV1 to deliver video, and adoption now spans smart TVs, streaming media players, mobile devices, web browsers, and chipsets. AV2, AOM’s successor to
Lattice to Showcase Industrial FPGA Innovations at FPGAWorld Conference 202625.8.2026 23:00:00 EEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced its exhibition plan for the upcoming FPGAWorld Conference 2026, taking place on Sept. 8, 2026, in Stockholm, Sweden. As part of the event, Lattice will deliver technical presentations and host a demo showcase focused on how its low power FPGA solutions are advancing Industrial IoT and sensor bridging applications. Who: Lattice Semiconductor What / When (GMT+2): Tuesday, Sept. 8, 2026 Lattice Demo Showcase Presentations (Track: 12:20 – 13:35, Room Brave 05) “Solving Your Power Puzzle: Lattice FPGAs’ Path to Uncompromised Low Power” “Practical Security Fundamentals for FPGA Engineers” Where: AFRY, Frösundaleden 2A, 169 70 Solna, Sweden The FPGAWorld Conference is an international forum for researchers, engineers, teachers, students, and hackers. It covers topics such as complex analog/digital/software FPGA SoC systems, FPGA/ASIC-based products, educational and industrial cases,
France Becomes First Official Participant at Expo 2030 Riyadh25.8.2026 20:40:00 EEST | Press release
France is the first country to officially sign its Participation Contract for Expo 2030 Riyadh, a major milestone in its preparations and growing international momentum. The signing took place on the sidelines of the visit to France by His Royal Highness Prince Mohammed bin Salman bin Abdulaziz Al Saud, Crown Prince and Prime Minister. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260825634516/en/ The ceremony in Paris was attended by H.H. Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, and Dimitri S. Kerkentzes, Secretary General of the BIE. The Participation Contract was signed by Talal Al-Marri, Chief Executive Officer of Expo 2030 Riyadh, and Jacques Maire, Chairman of the Compagnie Française des Expositions (COFREX). The agreement formally establishes France’s participation in Expo 2030 Riyadh, providing the framework for its presence throughout the six-month event. It spec
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