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
Sharjah Ruler Receives Portugal’s Grand Collar of Order of Camões31.1.2026 19:27:00 EET | Press release
His Excellency Marcelo Rebelo de Sousa, President of the Portuguese Republic, awarded His Highness Sheikh Dr Sultan bin Mohammed Al Qasimi, Supreme Council Member and Ruler of Sharjah, the Grand Collar of the Order of Camões (Grande Colar da Ordem de Camões), the highest sovereign cultural order in Portugal. His Highness is the first Arab figure to receive the Order of Camões and the sixth recipient worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260131119526/en/ Sharjah Ruler receives Portugal’s Grand Collar of Order of Camões (Photo: AETOSWire) The honour was conferred during a ceremony hosted by the Portuguese President at the Presidential Palace in Lisbon. The event was attended by Sheikha Bodour bint Sultan Al Qasimi, Chairperson of the Sharjah Book Authority, alongside senior officials. The ceremony recognised His Highness’s prominent global stature, as a leading figure in culture, intellectual thought and in
Incyte Announces Positive CHMP Opinion for Zynyz ® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)30.1.2026 16:29:00 EET | Press release
Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). “Today’s positive CHMP opinion is an important step towards addressing the urgent need for new treatment options for patients in Europe with advanced SCAC, a disease which has seen limited innovation for decades,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved, Zynyz in combination with platinum-based chemotherapy has the potential to become a new standard-of-care for patients living with this rare and difficult-to-treat cancer.” The positive CHMP opinion was based on data from the Phase 3 POD1UM-303/Inter
Mediawan to Acquire The North Road Company, Creating a New Global Independent Content Platform30.1.2026 14:32:00 EET | Press release
Mediawan, the leading independent European studio led by Pierre-Antoine Capton, co-founded by Capton, Xavier Niel and Matthieu Pigasse, today announced the signing of an agreement to acquire The North Road Company (“North Road”), the preeminent independent U.S.-based studio founded by Peter Chernin. The combination creates one of the world’s largest independent studios with major creative hubs in the five continents and capabilities spanning all genres, formats and audiences. Together, Mediawan and North Road will have a stronger ability to accelerate the development of powerful IP, foster fresh creative synergies through format adaptations and co-production opportunities, and deliver ever greater value to viewers, talent and partners worldwide. The acquisition brings together two of the most dynamic independent studios in the sector with world-class creative talent, premium IP, and the scale to deliver content at the highest level. In an industry undergoing significant consolidation,
BrightSign Powers Intelligent Signage Experiences at ISE 202630.1.2026 10:00:00 EET | Press release
With more industries embracing the power of visual storytelling, BrightSign, the provider of the most advanced, capable, and trusted digital media players and operating system, will showcase the latest developments in digital signage technology at ISE 2026 in Barcelona, Spain from February 3-6, 2026. BrightSign’s latest innovations come to life at booth #4S-150 through interactive real-world demos featuring retail, QSR, transportation, and corporate use cases. Visitors can test new AI-powered object detection capabilities of BrightSign players, allowing them to pick up an object and see the content on the screen respond immediately. Booth activations will be powered by BrightSign’s reliable platform including bsn.Control, BrightSignOS™, brightAuthor connected, and its global partner ecosystem. “In today’s immersive, personalized and visual world, the stakes have never been higher for powerful, secure, reliable, and intelligent digital signage,” said Steve Durkee, chief executive office
Candela Ushers in a New Era of Aesthetic Innovation at IMCAS Paris With the Launch of the Glacē™ System30.1.2026 09:30:00 EET | Press release
Candela, a global leader in energy-based aesthetic technologies, today announced the European launch of the Glacē™ System, a facial treatment platform that signals a bold new chapter for the company and the future of aesthetic medicine. In addition to the launch of the Glacē System, Candela will also showcase its Matrix system for radiofrequency-based skin renewal and its iconic Vbeam® Pro vascular treatment platform at IMCAS 2026. Both Matrix and VBeam Pro platforms are currently available in select EMEA markets and are expected to be comprehensively launched shortly, further strengthening Candela’s leadership in the energy-based device market. Unveiled at the IMCAS World Congress 2026, these launches underscore Candela’s continued commitment to delivering innovative, science-backed treatment solutions for high-demand patient needs. Candela leads the industry in clinical efficacy and safety, supported by one of the largest bodies of published clinical data backed by decades of clinica
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