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
Media Release: Financial Worries Rise and Match Health Concerns as Cost-of-Living Pressures Mount in 20266.7.2026 11:00:00 EEST | Press release
Households around the world are feeling the strain of the rising cost of living, with financial pressure increasingly shaping everyday choices and long-term confidence. Finances and health are now tied as the top global worries, at 48% each, followed by concerns about the future at 35%, according to consumer surveys in 10 countries published in “The Allianz 3am Report 2026.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260703907741/en/ Allianz / IPSOS “What Worries the World” Study, April – June 2026. Financial worries, which include concerns about “rising cost of living” (71%) and “insufficient income” (51%), increased in seven out of eight countries surveyed year over year, moving up in the ranking of top three worries in Brazil, France, Germany, and the U.K., while remaining stable in Italy. The strongest increases are observed in Australia and Indonesia, where financial concerns have remained the leading worry, as well
HAZAMA ANDO Becomes an Official Partner in Helical Fusion’s Commercial Fusion Initiative and Signs MoU Toward Construction of the Fusion Pilot Plant6.7.2026 09:40:00 EEST | Press release
Helical Fusion Co., Ltd. (“Helical Fusion”), a Japan-based fusion energy startup developing fusion power plants, and HAZAMA ANDO CORPORATION (“HAZAMA ANDO”), a long-established Japanese general contractor, today announced that HAZAMA ANDO has become an Official Partner in the Helix Program, Helical Fusion’s commercial fusion initiative. The two companies have also signed a memorandum of understanding (“MoU”) to collaborate toward the construction of Helix KANATA, Helical Fusion’s Fusion Pilot Plant targeted for the 2030s. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706176052/en/ (L-R) Kazuhiko Kuniya (Representative Director and President, HAZAMA ANDO CORPORATION) and Takaya Taguchi (Co-Founder and CEO, Helical Fusion Co., Ltd.) at a press conference in Tokyo on July 6, 2026. Fusion energy has the potential to shift the foundation of energy from natural resources to advanced technology by reproducing, on Earth, the sam
Sofinnova Partners Announces Myricx Bio Agrees to Be Acquired by Novartis6.7.2026 08:15:00 EEST | Press release
Sofinnova Partners, a leading European life sciences venture capital firm, today announced that its portfolio company Myricx Bio (“Myricx”) has reached agreement to be acquired by Novartis, for up to $1.5 billion including $1.1 billion cash upfront plus potential milestone payments. This marks Sofinnova Partners' seventh exit in three years. Myricx Bio is a UK-headquartered transatlantic biotech company focused on the discovery and development of a novel class of payloads for antibody-drug conjugates. The company's platform is built around next-generation N-myristoyltransferase inhibitor (NMTi) payloads, a differentiated mechanism of action designed to address the narrow therapeutic windows and tolerability challenges that have limited earlier generations of ADCs, such as TOPO-1 and tubulin inhibitor payload classes. Myricx Bio's two lead ADC assets, directed towards the established targets B7-H3 and HER2, are designed to bring this differentiated approach to patients across a broad ra
Global New Material International Wins Technology Innovation Best Practice Award at Sino-European ESG Conference6.7.2026 06:59:00 EEST | Press release
Global New Material International Holdings Ltd. has received the Technology Innovation Best Practice Award at the Third Sino-European Corporate ESG Best Practice Conference recently in Mainz, Germany, in recognition of its efforts to advance sustainable development through material innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260705533555/en/ Thorsten Giehler (L), Director of the Economic, Social Development and Employment Division of The German Society for International Cooperation (GIZ), delivered the award to Zhou Fangchao, Executive Director and Vice President of Global New Material International. The annual conference, initiated by the Chinese Consulate General in Frankfurt and jointly organized with Chinese and European partners, recognizes corporate best practices in environmental, social and governance (ESG) performance. This year's event brought together government officials, business leaders and exper
Access Advance Welcomes Samsung and Sharp to the VVC Advance Patent Pool6.7.2026 03:00:00 EEST | Press release
Access Advance LLC today announced significant additions to the VVC Advance Patent Pool, including Samsung Electronics and Sharp Corporation joining as both Licensors and Licensees. The additions strengthen Access Advance's position in VVC licensing, bringing two of the world's largest video codec patent holders into the program on both sides of the license. "The growth we are seeing in VVC Advance reflects the broad range of industries and companies that are moving toward VVC as the next standard for video delivery," said Peter Moller, CEO of Access Advance. "Samsung and Sharp joining as both Licensors and Licensees is significant, but so is the participation of leading smartphone brands and the range of consumer electronics and technology companies now executing licenses. We are building a program that reflects where the video market is actually heading." The following companies have joined the VVC Advance Patent Pool as Licensees since the beginning of 2026: American Future Technolo
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