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
Samos Energy Acquisition Corporation Announces Pricing of Initial Public Offering10.7.2026 16:32:00 EEST | Press release
Samos Energy Acquisition Corporation (the “Company”) announced today the pricing of its initial public offering (“IPO”) of 20,000,000 units at a price of $10.00 per unit. The units will be listed on the New York Stock Exchange (the “NYSE”) and trade under the ticker symbol “SAMO.U” beginning on July 10, 2026. Each unit consists of one Class A ordinary share and one-half of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one of the Company’s Class A ordinary shares at an exercise price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the NYSE under the symbols “SAMO” and “SAMO.WS,” respectively. Cantor Fitzgerald & Co. is acting as the sole book running manager for the proposed offering. The Company has granted the underwriter a 45-day option to purchase up to an additional 3,000,000 units at the IPO price. The public offering is being made
Onera hPSG ® Wins Prestigious Red Dot Product Design Award10.7.2026 16:00:00 EEST | Press release
Onera Health, a leader in transforming sleep medicine, announces that its innovative product, Onera hPSG®, has been honoured with the prestigious Red Dot Product Design Award for 2026. This international recognition celebrates exceptional design quality and underscores Onera Health's commitment to excellence, creativity, and patient-centric innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260710266668/en/ Onera Health's patch-based home polysomnography solution, Onera hPSG®, wins Prestigious Red Dot Product Design Award 2026. The Red Dot Award, one of the most sought-after seals of quality for good design, attracted thousands of entries from around the globe. Onera hPSG® stood out for outstanding functionality, striking aesthetics, and thoughtful user experience. The expert jury praised the product for translating complex sleep diagnostics into a wearable, easy-to-use system that enables low-threshold application.
teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening10.7.2026 10:00:00 EEST | Press release
teamLab Biovortex Kyoto has welcomed over 1 million visitors as of July 6, 2026, 9 months after its grand opening. (*1) These visitors arrived from more than 150 countries and regions. International visitors account for approximately 42% of the total. Many of these international visitors travel from distant countries and regions, including the United States, Australia, Canada, the United Kingdom, and Germany. Approximately 30% of these international visitors purchase their tickets at least 30 days in advance. teamLab Biovortex Kyoto is teamLab's largest museum in Japan, with an average visitor stay of over two and a half hours. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709913938/en/ teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening *1 According to ticket purchase data from the official teamLab Biovortex Kyoto website (survey period: October 7, 2025 – July 6, 2026) Visitors Comment (M
Robbyant Launches LingBot-VA 2.0 Built Natively for Embodied AI and Physical World Control10.7.2026 09:48:00 EEST | Press release
Robbyant, an embodied AI company within Ant Group, today announced the release of LingBot-VA 2.0, the industry’s first embodied-native video-action world model. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709654440/en/ A robot powered by LingBot-VA 2.0 engages in a real-time tabletop air hockey match with a human This release marks a key transition in robotics foundation models, shifting from repurposing digital world models to designing them natively for the physical world. Instead of relying on fine-tuned digital content generation models, LingBot-VA 2.0 is built from scratch to meet the original demands of dynamic modeling, causal prediction, and real-time execution in physical environments. Integrating world models with embodied AI has been one of the major focuses of the AI industry. However, most mainstream approaches rely on video generation models designed for digital content, which are then fine-tuned for robo
SureWerx Appoints Erik Pertot as VP/GM SureWerx EMEA10.7.2026 09:00:00 EEST | Press release
SureWerx, a leading global manufacturer of personal protective equipment, safety products, tools and equipment solutions, today announced the appointment of Erik Pertot as VP/GM SureWerx EMEA. Pertot will report directly to CEO Scott Dowell and will lead growth, manufacturing and M&A activities in Europe across the company’s global portfolio. Erik joins SureWerx with more than 20 years of international leadership experience across engineering, quality, marketing, sales, international supply chain, product management, and general management. He brings deep expertise in the personal protective equipment industry, with a track record of leading complex, compliance-critical programs, managing business transitions, and driving growth across multinational environments. Most recently, Pertot served as Global General Manager for Footwear and Fall Protection at Protective Industrial Products (PIP), where he also held senior portfolio management leadership roles. Prior to that, he held a series
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