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
Textron Aviation Marks 500th Cessna Citation Latitude Rollout22.9.2026 17:19:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE:TXT) company, today announced the rollout of the 500th Cessna Citation Latitude business jet from the company’s Wichita, Kansas, manufacturing facility. The production milestone highlights the continued success of the world’s best-selling midsize business jet and recognizes the employees whose craftsmanship and dedication have helped make the Citation Latitude the trusted choice for operators around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260922867287/en/ Textron Aviation marks 500th Cessna Citation Latitude rollout. (Photo Credit: Textron Aviation) “The rollout of the 500th Citation Latitude is a testament to the employees who build this aircraft with dedication and pride every day,” said Eric Cardinali, senior vice president, Manufacturing. “Behind every aircraft is a team committed to delivering the quality and craftsmanship our customers expect. This milestone
OCP Announces Date of Second Quarter and First Half 2026 Earnings22.9.2026 17:00:00 EEST | Press release
OCP S.A. (“OCP” or the “Company”), a global leader in the fertilizer industry, will release its second quarter and first half 2026 results on Tuesday, September 29, 2026. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal from 10:00 a.m. EDT, 2:00 p.m. Morocco (GMT) and 3:00 p.m. London time (GMT+1). OCP senior management will host a conference call to discuss second quarter and first half 2026 results at 11:00 a.m. EDT, 3:00 p.m. Morocco (GMT) and 4:00 p.m. London time (GMT+1) on Tuesday, September 29, 2026, for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma. About OCP OCP is a global leader in the fertilizer industry, backed by almost a century
Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 202622.9.2026 16:30:00 EEST | Press release
Takeda(TSE:4502/NYSE:TAK)announced that new data from its oncology pipeline and portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026, in Madrid, Spain. Key data will include a late-breaking abstract on arcotatug tavatecan (TAK-921; Innovent R&D code: IBI343*) and two presentations on TAK-928 (Innovent R&D code: IBI363*). Clinical and real-world analyses of ALUNBRIG® (brigatinib) and FRUZAQLA® (fruquintinib) will also be shared at the congress. “Takeda’s data at ESMO reflect our commitment to delivering rapid progress for patients living with some of the most prevalent and challenging cancers, including advanced gastric cancer and immunotherapy-resistant and previously untreated non-small cell lung cancer,” said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit at Takeda. “Our mission is to advance new therapeutic approaches for patients who need more options or who remain underserved by cur
Quaise Energy Selected for Up to $25 Million in U.S. Department of Energy Support to Advance World's First Commercial Superhot Geothermal Power Plant22.9.2026 16:30:00 EEST | Press release
Quaise Energy, a leading developer of utility-scale superhot geothermal energy, today announced that it has been selected by the U.S. Department of Energy (DOE) for up to $25 million in funding under the Next-Generation Geothermal Field Tests and Geothermal Resource Characterization and Confirmation funding opportunity. The support brings the U.S. closer to commercializing superhot Enhanced Geothermal Systems — technology that could unlock firm, clean power from hot rock beneath virtually any geography in the country. The funding will advance Project Obsidian, the world's first commercial superhot geothermal power plant, in Central Oregon. It will support analysis of the drilling, stimulation, and flow results of the first two wells to optimize a third well at the Obsidian site. The three-well configuration is targeting average reservoir temperatures of over 300°C and is designed to demonstrate more than 25 megawatts of gross electric power capacity. The DOE funding will also enable Qu
From CSR to Public Health Impact: How Colgate Bright Smiles, Bright Futures® is Driving Behavior Change for the Next Billion Children and Their Families22.9.2026 16:00:00 EEST | Press release
Colgate-Palmolive, the worldwide leader in oral care, announced a strategic evolution in its flagship oral health education program, Colgate Bright Smiles, Bright Futures® (BSBF), reflecting the Company’s commitment to global public health. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260922129016/en/ Launched in 1991, the program has reached over two billion children and their families across more than 100 countries, demonstrating how private-sector commitment designed to support communities, can become a powerful force for public health, driving healthier behaviors and positive outcomes at scale. From health education curriculum and school programming to mobile dental vans and free oral health screenings, BSBF helps children and their families access care, adopt healthier habits, and improve long-term oral health outcomes. “At Colgate-Palmolive, we believe oral health and healthier, brighter futures are inextricably link
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