Business Wire

ViiV Healthcare Announces US FDA Approval for Rukobia (fostemsavir), a First-in-Class Treatment for HIV in Adults With Few Treatment Options Available

Share

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations.

Significant advances over the past few decades have dramatically improved HIV treatment and for many, HIV is considered a manageable life-long condition. However, HTE adults – which account for approximately 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations.1 HTE adults are at risk of progressing to AIDS and death and in great need of additional therapies.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS. The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind.”

The approval was supported by data from the phase III BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimized background therapy (OBT) in HTE adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomized cohort, 60% (n=163/272) of individuals who received Rukobia in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through Week 96.

The proportion of participants who discontinued treatment with Rukobia due to an adverse event was 7% at Week 96 (randomized: 5% and nonrandomized: 12%). The most common adverse reactions (all grades) observed in ≥5% of randomized and nonrandomized participants were nausea, fatigue and diarrhea. The most common adverse events leading to discontinuation were related to infections (3%). Serious drug reactions occurred in 3% of people taking Rukobia and included three cases of severe immune reconstitution inflammatory syndrome.2

Jacob P. Lalezari, M.D., Chief Executive Officer and Director of Quest Clinical Research, said: “As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV. In the BRIGHTE study, fostemsavir in combination with other ARVs effectively achieved and maintained long-term viral suppression and demonstrated clinically meaningful rise in CD4+ T-cell count even among heavily immunocompromised patients. These are exciting advances for the HTE population and an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV.”

Rukobia was reviewed and approved under the FDA’s Fast Track and Breakthrough Therapy Designations which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Gabriel Maldonado, Founder and CEO, TruEvolution, Inc., said: “Some members of the HIV community face very challenging treatment journeys and do not respond to available therapies for a variety of reasons. The approval of fostemsavir provides a sense of renewed hope for these adults who have few or no viable treatment options left and have been awaiting alternative medicines to control the virus.”

Fostemsavir is currently under review by the European Medicines Agency and additional submissions to regulatory authorities around the world are planned throughout 2020 and 2021.

About BRIGHTE
The BRIGHTE trial is an international, phase III, partially-randomized, double-blind, placebo-controlled study conducted in 371 HTE adults living with HIV-1 infection with multidrug resistance. All trial participants were required to have a viral load ≥400 copies/mL and ≤2 classes of antiretroviral medications remaining at baseline due to resistance, intolerability, contraindication, or other safety considerations. Trial participants were enrolled in either a randomized or nonrandomized cohort defined as follows:

  • Within the randomized cohort (n = 272), participants had 1, but no more than 2, fully active and available antiretroviral agent(s) at screening which could be combined as part of an efficacious background regimen. Randomized participants received either blinded fostemsavir 600 mg twice daily (n = 203) or placebo (n = 69) in addition to their current failing regimen for 8 days of functional monotherapy. Beyond Day 8, randomized participants received open-label fostemsavir 600 mg twice daily plus an investigator-selected optimized background therapy (OBT).
  • Within the nonrandomized cohort (n = 99), participants had no fully active and approved antiretroviral agent(s) available at screening. Nonrandomized participants were treated with open-label fostemsavir 600 mg twice daily plus OBT from Day 1 onward. The use of an investigational drug(s) as a component of the optimised background therapy was permitted in the nonrandomized cohort.

The primary endpoint analysis, based on the adjusted mean decline in HIV-1 RNA from Day 1 at Day 8 in the randomized cohort, demonstrated superiority of fostemsavir to placebo (0.79 vs. 0.17 log10 copies/mL decline, respectively; P<0.0001, Intent-to-Treat-Exposed [ITT-E] population). In the randomized cohort, HIV-1 RNA <40 copies/mL was achieved in 53% and 60% of subjects at Weeks 24 and 96, respectively (ITT-E, Snapshot algorithm). Mean changes in CD4+ cell count from baseline continued to increase over time (i.e., 90 cells/mm3 at Week 24 and 205 cells/mm3 at Week 96). The most common adverse reaction (all grades) observed in ≥5% of participants were nausea. The proportion of participants who discontinued treatment with fostemsavir due to an adverse event was 7% at Week 96 (randomized: 5% and nonrandomized: 12%). In the nonrandomized cohort, HIV-1 RNA <40 copies/mL was achieved in 37% of subjects at Weeks 24 and 96. At these timepoints, the proportion of subjects with HIV-1 RNA <200 copies/mL was 42% and 39%, respectively (ITT-E, Snapshot algorithm). Mean changes in CD4+ cell count from baseline increased over time: 41 cells/mm3 at Week 24 and 119 cells/mm3 at Week 96. The most common adverse reactions reported in nonrandomized subjects were fatigue (7%), nausea (6%), and diarrhea (6%).

About Rukobia
The active ingredient in Rukobia is fostemsavir. Fostemsavir is a first-in-class HIV-1 attachment inhibitor. After oral administration, fostemsavir is converted to temsavir, which is then absorbed and exerts antiviral activity by attaching directly to the glycoprotein 120 (gp120) subunit on the surface of the virus, thereby blocking HIV from attaching to host immune system CD4+ T-cells and preventing the virus from infecting those cells and multiplying. As Rukobia is the first antiretroviral therapy to target this step of the viral cycle, there is no demonstrated resistance to other classes of antiretrovirals, which may help patients who have become resistant to most other medicines.

Important Safety Information (ISI)
The following ISI is based on the Highlights section of the Prescribing Information for RUKOBIA. Please consult the full Prescribing Information for all the labeled safety information for RUKOBIA.

INDICATIONS AND USAGE

  • RUKOBIA, a human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

DOSAGE AND ADMINISTRATION

  • One tablet taken twice daily with or without food.

DOSAGE FORMS AND STRENGTHS

  • Extended-release tablets: 600 mg

CONTRAINDICATIONS

  • Hypersensitivity to fostemsavir or any of the components of the formulation.
  • Coadministration with strong cytochrome P450 (CYP)3A inducers as significant decreases in temsavir plasma concentrations may occur, which may result in loss of virologic response.

WARNINGS AND PRECAUTIONS

  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapies.
  • QTc prolongation: Use RUKOBIA with caution in patients with a history of QTc prolongation or with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes.
  • Elevations in hepatic transaminases in patients with hepatitis B or C virus co-infection: Elevations in hepatic transaminases were observed in a greater proportion of subjects with HBV and/or HCV co-infection compared with those with HIV mono-infection.
  • Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: The concomitant use of RUKOBIA and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to 1) Loss of therapeutic effect of RUKOBIA and possible development of resistance due to reduced exposure of temsavir 2) Possible prolongation of QTc interval from increased exposure to temsavir.

ADVERSE REACTIONS

  • The most common adverse reactions (all grades) observed in ≥5% of randomized and non-randomized participants were nausea, fatigue and diarrhea.

DRUG INTERACTIONS

  • See full prescribing information for complete list of significant drug interactions.
  • Doses of oral contraceptives should not contain more than 30 mcg of ethinyl estradiol per day.

USE IN SPECIFIC POPULATIONS

  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission.

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 ViiV Healthcare’s Patient Support Program
ViiV Healthcare is committed to providing assistance to eligible people living with HIV who need our medicines. ViiV Healthcare’s centralised service, ViiV Connect, provides comprehensive information on access and coverage to help patients get their prescribed ViiV Healthcare medicines whether they are insured, underinsured or uninsured. ViiV Connect provides one-on-one support from dedicated access coordinators, as well as having an integrated website, one site with many resources, including a portal. For more information on ViiV Connect, visit www.viivconnect.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/about-us.

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 "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID19 pandemic.

_________________________
1 Hsu R, et al. Identifying Heavily Treatment-Experienced Patients in the OPERA Cohort. 22nd International AIDS Conference; July 23–27, 2018; Amsterdam, the Netherlands. Poster THPEB044.
2 Rukobia (fostemsavir) Prescribing Information. US Approval 2020.

Contact information

ViiV Healthcare Media enquiries:
Audrey Abernathy
+1 919 605 4521

Patricia O’Connor
+44 20 8047 5982

GSK Global Media enquiries:
Simon Steel
+44 (0) 20 8047 5502 (London)

Tim Foley
+44 (0) 20 8047 5502 (London)

GSK US Media enquiries:
Kristen Neese
+1 804 217 8147 (Philadelphia)

Kathleen Quinn
+1 202 603 5003 (Washington DC)

Analyst/Investor enquiries:
Sarah Elton-Farr
+44 (0) 20 8047 5194 (London)

Danielle Smith
+44 (0) 20 8047 0932 (London)

James Dodwell
+44 (0) 20 8047 2406 (London)

Jeff McLaughlin
+1 215 751 7002 (Philadelphia)

Frannie DeFranco
+1 215 751 4855 (Philadelphia)

About Business Wire

Business Wire
Business Wire



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

Lenovo Delivers Outstanding Q1 Performance and Strong Growth, Overcoming Challenging Global Environment13.8.2020 06:46:00 CESTPress release

Lenovo Group (HKSE: 992) PINK SHEETS: LNVGY) today announced Group revenue in the first quarter of US$13.3 billion, up almost 7% year-on-year (up 10% year-on-year excluding currency impact). Pre-tax income grew 38% compared to the same quarter a year earlier, to US$332 million, while net income also increased by 31% year-on-year to US$213 million. Basic earnings per share for the first quarter were 1.80 US cents or 13.95 HK cents. “Our outstanding performance last quarter proves that Lenovo has quickly regained momentum from the impact of the pandemic and is capturing the new opportunities emerging from remote working, education and accelerated digitalization,” said Yang Yuanqing, Lenovo Chairman and CEO. “While the world continues to face challenges, Lenovo is focused on delivering sustainable growth through our core businesses as well as the new services and solutions opportunities presented by our service-led intelligent transformation.” Global economic factors The last quarter has

Win a Tablet with WorldRemit’s Back to School Competition!13.8.2020 03:11:00 CESTPress release

WorldRemit, a leading international payments company, is giving away 150 tablet computers to students in the Philippines! Public schools in the Philippines are scheduled to reopen from 24th August, depending on compliance with the local COVID-19 Risk Severity Classification. WorldRemit, which has a large presence in the Philippines, wants to create opportunities by widening access to education with this generous offer. Customers will have the chance to win a tablet computer by simply making a transfer to the Philippines using the WorldRemit app or website between 1st July and 30th September 2020 and ensuring that they have registered for the offer online at: https://www.worldremit.com/en/promotions/winatablet. Every Friday of each week from 14th August 2020 until 2nd October 2020, WorldRemit will randomly select between 16 and 20 winners. A tablet computer will then be sent to the winners’ chosen recipient who can demonstrate they are currently a student in the Philippines. “As a compa

Lattice Sentry Solutions Stack and SupplyGuard Service Deliver End-to-End Supply Chain Protection with Dynamic Trust12.8.2020 22:00:00 CESTPress release

Lattice Semiconductor Corporation (NASDAQ: LSCC), the low power programmable leader, today launched the Lattice Sentry™ solutions stack and the Lattice SupplyGuard™ supply chain protection service. The Sentry stack is a robust combination of customizable embedded software, reference designs, IP, and development tools to accelerate the implementation of secure systems compliant with NIST Platform Firmware Resiliency (PFR) Guidelines (NIST SP-800-193). The Lattice SupplyGuard service extends the system protection provided by the Sentry stack throughout today’s challenging and rapidly changing supply chain by delivering factory-locked devices to protect them from attacks like cloning and malware insertion, and enables secure device ownership transfer. These hardware security solutions are increasingly important to a range of applications, including communications, datacenter, industrial, automotive, aerospace, and client computing. This press release features multimedia. View the full rel

Phase III InPedILD™ trial enrolls first patient to evaluate nintedanib in pediatric population with fibrosing interstitial lung disease12.8.2020 14:36:00 CESTPress release

Boehringer Ingelheim today announced that the first patient has enrolled in InPedILD™, a global Phase III trial assessing the dosing and safety profile of nintedanib in children and adolescents between six and 17 years old with clinically significant fibrosing interstitial lung disease (ILD). Childhood ILD (chILD) includes more than 200 rare respiratory disorders that can affect infants, children and adolescents, making it difficult for them to breathe. In some cases, fibrosis which involves scarring and damage to the lungs can develop. This can lead to a significant impact on the daily life of those affected, as well as their families, including high morbidity and mortality. There are currently no approved therapies available for the treatment of chILD. “Some children with interstitial lung disease may develop serious fibrosis that progresses,” said the coordinating investigator Prof. Robin Deterding, M.D., Director of the Breathing Institute, Children's Hospital Colorado. “Though the

Velodyne Lidar Powering Intelligent Traffic Management in Nevada12.8.2020 14:00:00 CESTPress release

Velodyne Lidar, Inc. today announced a partnership with University of Nevada, Reno to advance research in transportation infrastructure. The university’s Nevada Center for Applied Research purchased and, in conjunction with the Nevada DOT and Nevada Governor’s Office of Economic Development, is using Velodyne’s lidar sensors in its Intelligent Mobility initiative to collect data aimed at making transportation more efficient, sustainable and safe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005076/en/ The University of Nevada, Reno’s Nevada Center for Applied Research has integrated Velodyne Ultra Puck lidar sensors with traffic signals to detect, count and track pedestrians, cyclists and traffic. (Photo: Velodyne Lidar, Inc.) The program has integrated Velodyne Ultra Puck lidar sensors with traffic signals to detect, count and track pedestrians, cyclists and traffic to help improve traffic analytics, congestion mana

Moody’s Analytics Three-Peats in Two Categories at Risk Technology Awards12.8.2020 13:30:00 CESTPress release

For the third straight year, Moody’s Analytics has won the Risk Technology Awards for Credit Data Provider of the Year and Wholesale Credit Modelling Software of the Year. These are two of our seven 2020 Risk Technology Awards spanning finance, accounting, regulatory, and credit functions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005119/en/ “Our clients rely on Moody’s Analytics for a fast and comprehensive view of their credit risk exposure,” said Nihil Patel, Managing Director at Moody’s Analytics. “The pandemic has accelerated their need to consider multiple forward-looking signals to assess credit risk. We continue to invest—in more asset class coverage, in alternative data sources, in machine learning that produces new analytics and insights—to ensure that our clients have all the information they need to address their most pressing business needs.” Extensive credit data and modeling capabilities feature in

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