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
Boomi Delivers the Critical Infrastructure That Brings Control to Enterprise AI2.9.2026 04:00:00 EEST | Press release
Boomi, the data activation company for AI, today announced major platform innovations designed to solve critical barriers to enterprise AI adoption. At the core of these updates is Boomi’s Agent Control Plane, AI-native infrastructure that securely connects AI agents to core business systems, provides governance over agent activity, and controls runaway AI costs. This critical infrastructure runs flexibly across public cloud, the customer’s own cloud (VPC), or on-premises, directly supporting data and digital sovereignty, and giving organizations greater operational control over their AI estate. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901851538/en/ Boomi Delivers the Critical Infrastructure That Brings Control to Enterprise AI Key Takeaways Boomi’s Agent Control Plane provides the critical AI-native infrastructure that operationalizes agentic workloads with full control. Vendor and model-neutral, it connects AI age
Goku Technologies Chooses SS&C for Fund Services2.9.2026 04:00:00 EEST | Press release
SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that Singapore Goku Technologies Pte. Ltd., an AI-driven quantitative investment manager, has chosen SS&C as its fund services provider. The firm, with offices in Shanghai and Singapore, employs systematic trading strategies to invest in equities across Asia, with USD4 billion in assets under management. SS&C GlobeOp will provide fund administration services for the Goku Technologies Master Fund. The fund operates a high-volume trading strategy with substantial daily trading activity. SS&C will support the fund through a comprehensive suite of services including fund accounting and investor services, helping Goku Technologies build a scalable operating model. “As our business has grown, so have our demands on our trading and operational framework,” said Ken Chung, CEO of Singapore Goku Technologies. “We are building an institutional quality operations infrastructure, so we needed a provider capable of supporting a high-vol
Meraki Capital Launches Tessero Across Six European Markets Following Landmark Hays Acquisition1.9.2026 23:36:00 EEST | Press release
Meraki Capital has launched Tessero,a new European specialist recruitment group created from the six former Hays plc businesses it acquired earlier this summer. Launching simultaneously across Sweden, Denmark, Hungary, Romania, Luxembourg and Czechia, Tessero brings six established recruitment businesses together under one independent European brand, creating an international platform with experienced teams, existing clients and active candidate networks from day one. The launch follows one of the most significant transactions in Meraki Capital’s history and the completion of a major transition programme across all six countries within weeks of the acquisition. 130 employees will now operate under the Tessero brand, with established country leadership teams remaining in place and continuing to lead their respective markets. Gary Elden OBE, CEO of Meraki Capital and Director of Tessero, said: “Tessero launches with something that normally takes years to build: established businesses, ex
SBC Medical to Participate in Several Upcoming Investor Conferences in September 20261.9.2026 20:35:00 EEST | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced its participation in several upcoming investor conferences in September 2026. SBC Medical will conduct presentations and one-on-one meetings with institutional investors. Below is a summary of the Company’s scheduled participation in upcoming investor conferences: H.C. Wainwright 28th Annual Global Investment Conference Date: September 14 2026 Format: In-person (NY) Registration: https://my.ct.events/register.aspx?meid=cff43623-9e9f-45d4-bbc3-ee19e9c372c1&rpid=a667ca45-171e-4306-98eb-c466e8b7e6c1 ArcStone Kingswood Growth Summit 2026 Date: September 16 2026 Format: In-person (Toronto) Registration:https://www.meetmax.com/sched/event_144037/investor_reg_new.html?attendee_role_id=ARCSTONE_ATTENDEE CLSA 33rd Investors’ Forum 2026 Date: September 21, 2026 Format: In-person (Hong K
Crimson Moon Available Now, Bringing Heavy-Metal Gothic Action to Solo and Co-op Players on PC, PlayStation 5, and Xbox Series X|S1.9.2026 20:00:00 EEST | Press release
ProbablyMonsters, an independent video game company creating original AA games with AAA sensibilities, today launched Crimson Moon on PC via Steam and Epic Game Store, PlayStation 5, and Xbox Series X|S for $19.99 USD. A $29.99 USD Deluxe Edition is also available and includes an exclusive armor set, weapon cosmetic, and upcoming game expansion. Watch the official Crimson Moon launch trailer on YouTube to see the game’s gothic heavy-metal power fantasy, crafted for both solo and co-op players, in action. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901064893/en/ Crimson Moon is a gothic high renaissance action-adventure RPG built around intense, replayable missions that blend brutal precision with deep character progression. Players take on the role of the Nephilim, powerful human-angel hybrids bound to a dark prophecy and charged with reclaiming the besieged city of Gildenarch from a horde of demons, undead, vampires,
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