ViiV Healthcare Gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. The 2-drug regimen comprises dolutegravir 50mg (ViiV Healthcare) and rilpivirine 25mg (Janssen Sciences Ireland UC).
Deborah Waterhouse, Chief Executive Officer at ViiV Healthcare commented: “Today is an important milestone for people living with HIV in Europe. It takes us a step closer to offering the first, single-pill, 2-drug regimen with the opportunity to reduce the number of drugs needed to treat HIV in those who are virologically suppressed; Juluca is expected to be the smallest single-pill regimen in the market. ViiV Healthcare is committed to delivering advances in HIV care, including providing innovative treatment options that meet the evolving needs of people living with HIV and we are willing to challenge the traditional HIV treatment paradigms to deliver these advances.”
The CHMP positive opinion follows the United States Food and Drug Administration approval of Juluca in November 2017 for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine;1 and is supported by data from two pivotal phase III clinical trials, SWORD-1 and SWORD-2, and a pivotal bioequivalence study.2,3
Positive data from the SWORD studies, recently published in The Lancet (5th January 2018), showed that the dolutegravir and rilpivirine regimen is non-inferior to three and four drug regimens in maintaining virologic suppression (HIV-1 RNA less than 50 copies per mL) through 48 weeks in adults who are infected with HIV-1 and have no history of resistance or treatment failure, in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (dolutegravir+rilpivirine 486/513 [95%] current antiretroviral regimen 485/511 [95%], [adjusted difference -0.2% (95% confidence interval: -3.0%, 2.5%), pooled analysis]). Virologic suppression rates were similar between treatment arms.2
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented: “We believe no one should have to take more medicines than they need, and dolutegravir/rilpivirine represents our first 2-drug regimen that could reduce the number of antiretrovirals people living with HIV in Europe take daily, whilst maintaining the efficacy of traditional three-drug regimens. Our research efforts are exploring a number of two-drug regimen treatment options that look beyond viral load and may address unresolved issues, such as long-term toxicity and reducing the number of drugs used in dosing.”
A CHMP opinion is one of the last regulatory steps before marketing authorisation is granted by the European Commission (EC). The final EC decision on European approval for dolutegravir/rilpivirine is anticipated towards the end of the second quarter of 2018.
– Ends –
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced a collaboration to investigate the potential of combining dolutegravir and rilpivirine in a single pill in order to expand the treatment options available to people living with HIV.
HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.
HIV has largely become a chronic treatable disease with improved access to antiretroviral treatment. This has led to a 22% drop in global HIV mortality between 2009 and 2013,4 but more can be done for the estimated 36.7 million people living with HIV4 of which 160,000 were newly diagnosed in the Europe region alone in 2016.5
Dolutegravir/rilpivirine was approved by the US Food and Drug Administration (FDA) on 21st November 2017, as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine.1
Dolutegravir/rilpivirine is a 2-drug regimen, once-daily, single pill that combines the integrase strand transfer inhibitor (INSTI) dolutegravir (50mg), with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (25mg) taken once-daily as a complete HIV regimen for people living with HIV who are virologically suppressed.
Two essential steps in the HIV life cycle include reverse transcription – when the virus turns its RNA (ribonucleic acid) copy into DNA (deoxyribonucleic acid) – and integration – the moment when viral DNA becomes part of the host cell’s DNA. These processes require two enzymes called nucleoside reverse transcriptase and integrase. NNRTIs and INSTIs interfere with the action of these two enzymes to prevent the virus from replicating. This decrease in replication can lead to less virus being available to cause subsequent infection of uninfected cells.
ViiV Healthcare has also submitted regulatory marketing applications in Canada, Australia and Switzerland.
About the SWORD phase III programme for dolutegravir (Tivicay) and
The SWORD phase III programme evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four-drug regimen. SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy (full 148-week data will be shared in 2019). In the SWORD clinical trials, dolutegravir and rilpivirine are provided as individual tablets.
The primary endpoint is the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The studies also include exploratory measures to assess change in health-related quality of life, willingness to switch and adherence to treatment regimens.
For more information on the trials please visit: www.clinicaltrials.gov
Juluca and Tivicay are trademarks owned by the ViiV Healthcare group of companies.
EDURANT is a registered trademark of Janssen Sciences Ireland UC.
Important Safety Information for dolutegravir/rilpivirine in Europe: Please refer to the full European Summary of Product Characteristics for full prescribing information for dolutegravir and rilpivirine.
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.
GSK - 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.
1 Juluca (dolutegravir and rilpivirine) Prescribing Information. Initial U.S Approval: 2017
2 Llibre JM, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. The Lancet. Published online January 5, 2018 http://dx.doi.org/10.1016/S0140-6736(17)33095-7.
3 Metha R, et al. Bioequivalence of a fixed dose combination tablet of dolutegravir and rilpivirine in healthy subjects. Presented at the 18th Workshop on Clinical Pharmacology of Antiviral Therapy, 2017. Chicago, United States.
4 World Health Organization. Global Update on the health sector response to HIV, 2014. July 2014. Available at: http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1. Last accessed March 2018.
5 World Health Organization. Infographic. Available at: http://www.euro.who.int/en/health-topics/communicable-diseases/hivaids/data-and-statistics/infographic-newly-diagnosed-hiv-infections-in-the-who-european-region,-2016. Last accessed March 2018.
+44 (0) 20-8047-5502
+44 (0) 20-8047-5502
+44 (0) 20-8047-5194
+44 (0) 20-8047-5503
+44 (0) 20-8047-2406
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
New SPINRAZA® (nusinersen) Data Unveiled at AAN Annual Meeting Show Continued Improvement in Motor Function for Broad Age Range and Survival Benefit for Infants23.4.2018 11:30 | Pressemelding
Biogen (Nasdaq: BIIB) today announced new findings detailing the benefits that SPINRAZA® (nusinersen) demonstrates for both infantile- and later-onset spinal muscular atrophy (SMA) populations, including improvement in motor function as well as increased survival for the most severely affected. These findings are based on interim results from the SHINE open-label extension study and an analysis of SPINRAZA’s effects on mobility and fatigability in later-onset participants from the CS2/CS12 studies. The research will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 21-27, 2018, in Los Angeles, California. “These results reinforce SPINRAZA’s unprecedented and compelling efficacy across a broad range of SMA populations, enabling patients to improve mobility and motor function – and, for the most severely affected, increase their chances of survival,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “We look for
Country Leaders Inspired by ABB’s Breakthrough E-Mobility Technologies23.4.2018 11:06 | Pressemelding
The two leaders, along with ABB CEO Ulrich Spiesshofer, were shown a demonstration of the company’s new high power fast charging solution: the Terra HP EV charging station with a power output of up to 350 kW recharges a car battery in just eight minutes for 200 km reach. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180423005618/en/ From left to right: German Chancellor Angela Merkel, Mexican President Enrique Peña Nieto, ABB CEO Ulrich Spiesshofer, First Lady Mrs. Angélica Rivera, Managing Director of ABB Germany Hans-Georg Krabbe, Managing Director of ABB Mexico Vicente Magana (Photo: Business Wire) “This high-power fast charger provides electric vehicles with up to seven times more range in the same charging time than with previous models,” Spiesshofer said. “Together with our comprehensive ABB AbilityTM digital offering, we easily connect chargers to back offices, payment platforms or smart grid systems and offer our cu
Panasonic Launches Off-grid Solutions Projectto Mark Its Centenary23.4.2018 10:07 | Pressemelding
Panasonic Corporation announced it has kicked off a project for people living in off-grid areas that combines educational activities to promote understanding of electricity and provision of the company’s related products. The Off-grid Solutions Project is part of Panasonic’s corporate social responsibility initiatives, celebrating the centennial of the company’s founding this year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180423005551/en/ Power Supply Station installed in Indonesia as part of the project (West Kalimantan) (Photo: Business Wire) This new initiative aims to support the creation of a sustainable society where each individual living without access to the power grid can lead an independent life. Panasonic will donate its products such as solar generation and storage systems, provide education and technical training to cultivate human resources, and help develop local business models taking advantage of elec
CORRECTING and REPLACING FlexTrade Launches FlexNOW Execution Management System (EMS)23.4.2018 08:56 | Pressemelding
Quote in sixth paragraph should be attributed to Lucas Howarth, Fund Manager at Wesleyan (sted of Chris Beton, CTO/CRO at Everett Capital Advisors). The corrected release reads: FLEXTRADE LAUNCHES FLEXNOW EXECUTION MANAGEMENT SYSTEM (EMS) – One-Click Deployment System for Hedge Funds and Mini-Primes – – MiFID II Compliant Trading for Equities, Futures & Options – FlexTrade (@FlexTrade) today announced the official release of FlexNOW, an out-of-the-box, broker neutral EMS to address the needs of hedge funds and mini-primes who require a streamlined, multi-asset trading system at the click of a button. Multi-Asset, MiFID II Compliant Trading -- Designed to handle trading for equities, futures and options, FlexNOW is MiFID II compliant; provides connectivity to leading market data providers; easily integrates with any order management system (OMS) via FIX and API; and comes with its own built-in transaction cost analysis functionality. Easy Installation -- According to Rhyd Lewis, FlexNOW
FlexTrade Launches FlexNOW Execution Management System (EMS)23.4.2018 08:00 | Pressemelding
FlexTrade (@FlexTrade) today announced the official release of FlexNOW, an out-of-the-box, broker neutral EMS to address the needs of hedge funds and mini-primes who require a streamlined, multi-asset trading system at the click of a button. Multi-Asset, MiFID II Compliant Trading -- Designed to handle trading for equities, futures and options, FlexNOW is MiFID II compliant; provides connectivity to leading market data providers; easily integrates with any order management system (OMS) via FIX and API; and comes with its own built-in transaction cost analysis functionality. Easy Installation -- According to Rhyd Lewis, FlexNOW Product Manager at FlexTrade UK, FlexNOW’s zero-touch onboarding and installation process gets clients up and running in a matter of minutes. “By combining the one-click installation process with secure, online connectivity, we have greatly reduced the on-boarding lead time for customers,” said Lewis. Streamlined Trading Workflows -- “We developed FlexNOW based o
Limited Edition Skechers D’Lites & Toei Animation One Piece Collection to Launch in Europe23.4.2018 07:00 | Pressemelding
After initially launching in Asia and with an upcoming debut in the United States and Canada, SKECHERS USA, Inc. (NYSE:SKX) is extending its popular anime collaboration to Europe as well with the launch of Skechers X One Piece. The colorful collection unites Toei Animation’s popular anime series with Skechers D’Lites, one of the footwear company’s original styles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180423005239/en/ Skechers launches limited edition One Piece collection in Europe (Photo: Business Wire) “Pairing the iconic long-running anime series One Piece with one of our top heritage styles resonated with our consumers in South Korea and China who have been driving trends for the past few years,” began Michael Greenberg, president of Skechers. “And now fashion moves at light speed, so as influencers around the world had already been embracing Skechers D’Lites and the chunky sneaker trend, we started to see style