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
HOF Capital Completes €1 Billion Acquisition of Porsche’s Stakes in Bugatti Rimac and Rimac Group9.9.2026 19:00:00 EEST | Press release
HOF Capital today announced the completion of its acquisition of Porsche’s equity interests in Bugatti Rimac and Rimac Group through an HOF-led consortium. The transaction, first announced in April 2026, closed following the satisfaction of all conditions, including regulatory clearances. Porsche’s combined interests were valued at approximately €1 billion. HOF Capital originated and led the transaction, assembling a consortium of institutional investors from the United States and Europe. Following completion of the transaction, HOF holds a 23.5% stake and becomes the largest shareholder in Rimac Group, which holds the 55% controlling interest in Bugatti Rimac. HOF and its consortium also acquired Porsche’s direct 45% interest in Bugatti Rimac. As part of the investment, HOF Capital holds three supervisory board seats across Rimac Group and Bugatti Rimac. Hisham Elhaddad, Co-Founder and Managing Partner of HOF Capital, has joined the Supervisory Boards of both Bugatti Rimac and Rimac G
The Rock-It Company Expands Dynamic Dox to Provide ATA Carnet Services Across the US and Canada9.9.2026 18:00:00 EEST | Press release
The Rock-It Company announced today the expansion of Dynamic Dox, the industry-leading provider of ATA Carnets, to now service partners and projects based in the United States, Canada and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909137375/en/ Following over a decade of expertise and leading service across the United Kingdom since 2014, Dynamic Dox will now provide new regions with dedicated document preparation for time-sensitive logistics projects, and urgent ATA Carnets for international shipments and critical business travel needs. The news of the expansion follows Dynamic Dox’s recent brand refresh, introducing an updated identity and connection to The Rock-It Company as Dynamic Dox By Rock-It. The expansion is led by Amanda Barlow, VP of Global ATA Carnets at The Rock-It Company, who has helped to drive the platform’s growth in ATA Carnets, customs services and beyond. The Rock-It Company recently enabl
Ennov Appoints Oxana Pickeral as Chief Executive Officer9.9.2026 17:00:00 EEST | Press release
Ennov (the “Company”), a global provider of a unified compliance platform that streamlines regulatory, clinical, quality, and pharmacovigilance operations for life sciences and healthcare companies, today announced the appointment of Dr. Oxana Pickeral as Chief Executive Officer. Founder and outgoing CEO, Olivier Pâris, will join Ennov’s Board of Directors and continue to support the company as a Strategic Advisor. Dr. Pickeral has spent her career at the forefront of innovation in life sciences technology, from her early work on the Human Genome Project to growing Amazon Web Services’ Healthcare & Life Sciences partner business, enabling modern cloud solutions across the industry. She joins Ennov most recently from Honeywell, where she served as Global Software and Connected Life Sciences business leader, and previously as President and CEO of Sparta Systems, a Honeywell company. Across her leadership roles, she has successfully scaled global companies at the intersection of life scie
Three Chugai Researchers Behind the Discovery of Hemlibra for Hemophilia A Receive Prestigious U.S. Lasker Award, One of the World’s Most Respected Scientific Honors9.9.2026 16:45:00 EEST | Press release
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that Dr. Kunihiro Hattori (former Senior Fellow of Chugai), Dr. Takehisa Kitazawa (Deputy Head of Research Division, Chugai), and Dr. Tomoyuki Igawa (Head of Research Division, Chugai), who led the creation of Hemlibra (emicizumab), a treatment for hemophilia A, have been awarded the Lasker-DeBakey Clinical Medical Research Award, one of the world's most prestigious scientific honors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909923883/en/ From left: Dr. Kitazawa, Dr. Hattori, and Dr. Igawa Hemophilia A is caused by a deficiency of coagulation Factor VIII, one of the proteins required for normal blood clotting. When activated, Factor VIII serves as a bridge that facilitates the activation of Factor X by activated Factor IX on the surface of activated platelets. The award recognizes the unconventional concept of replacing this function of Factor VIII with a
AMCS Appoints Richard Humphrey as Chief Product and Technology Officer9.9.2026 16:00:00 EEST | Press release
AMCS, a leading technology provider for the waste and recycling industry, today announced the appointment of Richard Humphrey as Chief Product and Technology Officer. Based in Boston, Humphrey will lead the company’s global product organisation. Humphrey brings more than 25 years of experience developing software for construction and other complex industrial environments. He joins AMCS as the company deepens its focus on waste and recycling and expands the role of AI across its platform. Most recently, Humphrey served as Chief Product and Technology Officer at Contruent, where he led product strategy for a construction cost-management platform used on major capital programmes. He previously held vice president roles at Bentley Systems and B2W Software. Earlier in his career, he spent more than a decade at Autodesk, where he led its Civil Design and Construction software business as Senior Director. “Richard understands what it takes to build software for industries where the work is ex
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