Janssen Receives Positive CHMP Opinion for SYMTUZA™ The First Darunavir-Based Single-Tablet Regimen for the Treatment of HIV
Janssen-Cilag International NV (Janssen) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for SYMTUZA™ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), a once-daily darunavir-based single tablet regimen (STR).
If approved, it will be the only darunavir-based STR indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg, with genotypic testing guiding use. This STR combines the proven efficacy and durability of darunavir with the improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (tenofovir disoproxil fumarate), and will be the only treatment that could deliver the adherence advantages of a STR coupled with the high genetic barrier to resistance that darunavir offers.
“Darunavir is one of the most widely used HIV treatments in the European Union due to its ability to control the HIV virus while offering a high barrier to resistance. We will now be able to combine a complete darunavir-based HIV treatment regimen into a once daily tablet. We are extremely excited to be one step closer to getting this therapy to people living with HIV and in doing so hope to reduce the treatment burden faced by many living with the virus,” said Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Janssen Infectious Diseases Therapeutics.
“A darunavir-based STR represents a significant evolution in treatment options for HIV patients,” said Jean-Michel Molina, Professor of Infectious Diseases at the University of Paris Diderot. “With around two million people in Europe currently managing their HIV, this is a true advancement in helping patients achieve an undetectable viral load and improving quality of life. Reducing the pill burden allows people greater freedom and flexibility, and through this we may also improve treatment adherence.”
The Positive Opinion is based on a bioequivalence study comparing the once-daily STR with the combined administration of the separate agents darunavir [D] 800 mg, cobicistat [C] 150 mg, and emtricitabine/tenofovir alafenamide [FTC/TAF] 200 mg/10 mg fixed-dose combination. A Phase 3 clinical trial programme investigating the efficacy and safety of the darunavir-based combination is underway. Data on the bioequivalence study, as well as interim data from the Phase 3 Pivotal EMERALD trial in virologically suppressed antiretroviral therapy (ART) experienced patients, who were switched to the STR, will be presented at the upcoming International AIDS Society (IAS) conference in Paris, France. Further EMERALD 48-week data, and 48-week data from the Phase 3 AMBER trial in ART naïve patients, will be released in due course. Please visit www.jnj.com/HIV for further details on the breadth of science being presented by Johnson & Johnson companies and its partners.
The CHMP's Positive Opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorisation for medicines in the European Economic Area. The European Commission’s final decision is anticipated in the coming months.
Janssen have brought medicines to market across a range of patient populations that have helped to transform the efficacy and tolerability of treatment. Treatment regimens that combine D/C (REZOLSTA®, Janssen-Cilag International NV, U.S name PREZCOBIX®) and F/TAF (DESCOVY®, Gilead Sciences International Ltd) are currently approved1,2 for the treatment of HIV. SYMTUZA™ is a significant evolution of this approach, combining both treatments in a single, convenient tablet, and is part of Janssen’s broader commitment to develop effective and innovative therapies which address the issues of adherence and resistance.
Notes to editors
On 23 December 2014, Janssen and Gilead Sciences International Ltd amended a licensing agreement for the development and commercialisation of a once-daily STR combination of darunavir and Gilead's TAF, emtricitabine and cobicistat. Under the terms of the agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution and commercialisation of this STR worldwide.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea/ and follow us at @JanssenEMEA.
About PREZISTA ® (darunavir)
PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.
PREZISTA, co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
In deciding to initiate treatment with PREZISTA co-administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
About REZOLSTA ® (darunavir/cobicistat)
REZOLSTA is an antiviral medicine used, in combination with other medicines, to treat adults with human immunodeficiency virus type 1 (HIV-1). REZOLSTA contains the active substances darunavir and cobicistat. The medicine is for use only in patients who have not received HIV treatment before or previously treated patients whose disease is not expected to be resistant to darunavir and who are healthy enough and have HIV virus levels below a certain threshold.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new indications and therapeutic combinations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the year ended January 1, 2017, including under “Item 1A Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1. European Medicines Agency:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002819/human_med_001817.jsp&mid=WC0b01ac058001d124 Last accessed June 2017.
2. European Medicines Agency:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004094/human_med_001978.jsp&mid=WC0b01ac058001d124 Last accessed June 2017.
+ 33 6 88 09 33 35
Phone: +1 732-524-3922
Joseph J. Wolk
Phone: +1 732-524-1142
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
Pandora to Acquire Leading Digital Audio Ad Tech Firm AdsWizz21.3.2018 13:00 | Pressemelding
Pandora (NYSE: P), the largest music streaming service in the U.S., today announced it will acquire AdsWizz, the global leader in digital audio ad technology. The addition of AdsWizz will upgrade Pandora’s ad tech capabilities, provide its advertisers with greater audience reach, and expand the company’s revenue opportunities. AdsWizz is one of the few ad tech firms that is completely dedicated to digital audio, serving some of the largest players in the industry. With digital audio advertising growing 42% year-over-year, according to the IAB, the combined offering of Pandora and AdsWizz will capitalize on this trend, while making it easier for publishers to monetize their inventory, and for advertisers to buy and measure their campaigns. “Since I joined Pandora six months ago, I have highlighted ad tech as a key area of investment for us. Today we took an important step to advance that priority and accelerate our product roadmap,” said Roger Lynch, CEO of Pandora. “With our scale in a
Fintech Entrepreneur and myPOS Founder Christo Georgiev Reveals Plans to Set Up a Chain of myPOS Stores across Europe21.3.2018 12:51 | Pressemelding
Founder of myPOS, Christo Georgiev announces plans to open myPOS flagship stores across Europe in an effort to bring the service closer to its customers. Designed for small and mid-sized businesses, myPOS offers affordable payment acceptance tools, winning the trust of over 40,000 enterprises across the EEA & Switzerland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180321005596/en/ An interior view of the myPOS London Store (Photo: Business Wire) Until now, the operational framework of myPOS included a network of promoters in almost every European country and an online store, owned and operated by myPOS. The next logical step was to sell through physical stores. On 8th February 2018, myPOS opened doors to its first flagship store, located on 36 Knightsbridge, London and marked the beginning of a new era for myPOS. Soon after, plans were revealed for other openings in Europe with another location coming up on 5th April 201
AI Expo Europe: The leading Artificial Intelligence Event to Arrive in the European Capital of Innovation, Amsterdam21.3.2018 12:47 | Pressemelding
The AI Expo Europe is set to arrive in the hub of AI innovation, Amsterdam, The Netherlands, this Summer (27-28th June) with an aim of ‘delivering AI for a smarter future.’ The well-connected Dutch capital is known for its unique, rich culture and canal-side views and was even awarded the European Capital of Innovation in 2016 by the European Commission. The city’s AI scene is thriving with the arrival of a world-class artificial intelligence hub by early 2021 and venture capitalist investment. The AI hub will be created in collaboration with the University of Amsterdam (UvA) and the City of Amsterdam at the Amsterdam Science Park, a place where education, research and entrepreneurship will come together as one. Geert ten Dam, president of the UvA’s Executive Board stated that: “Amsterdam is widely recognised both in the Netherlands and abroad for its leading scientific expertise in the area of AI…” This press release features multimedia. View the full release here: https://www.busines
Philip Morris International Shifts Entire Capacity of Its Cigarette Factory in Greece to Smoke-Free Products21.3.2018 12:31 | Pressemelding
Philip Morris International Inc. (PMI) (NYSE: PM) announced today that the factory of its Greek affiliate (Papastratos) in Aspropyrgos, has ceased cigarette production and is now exclusively producing HEETS, the tobacco units used with IQOS, the company’s most advanced smoke-free product. This first full conversion of a cigarette factory is a landmark step in our vision of a smoke-free future where people who smoke switch from the most harmful form of nicotine consumption – cigarettes – to scientifically substantiated smoke-free alternatives. The EUR 300 million investment included the construction of three new buildings and the replacement of cigarette production lines with high-tech facilities capable of producing 10,000 smoke-free tobacco units per minute. The conversion of the factory started in August 2017. The facility is expected to be fully operational by the end of 2018 and will create 400 new jobs. André Calantzopoulos, PMI’s Chief Executive Officer said: “This is a historic
GSMA Advances a Comprehensive Agenda on Digital Inclusion for Women Ahead of G20 Summit21.3.2018 12:00 | Pressemelding
The GSMA is supporting the sixty-second meeting of the Commission on the Status of Women (CSW62) taking place at the United Nations Headquarters in New York this month1 as part of its commitment to the Sustainable Developments Goals (SDGs), particularly SDG 5 (Gender Equality). The GSMA’s role at the event reflects its status as Topic Chair of the Digital Inclusion theme within the W20 (Women 20) group2, which will advise the G20 member states on issues around gender equality and the economic empowerment of women. At CSW62, the GSMA and its partners will be convening parallel events across a range of topics in this area, bringing together companies in the mobile ecosystem, governments, UN agencies and NGOs. “Developing forward-looking policies that promote digital inclusion for women is vital to achieving gender equality, serving to empower women in all corners of the world as well as providing an effective catalyst for economic growth,” said Mats Granryd, Director General of the GSMA.
fundinfo Launches New Fund News Service in Cooperation with UBS21.3.2018 08:00 | Pressemelding
To provide investors with up-to-date information and views from the fund managers with which they are invested fundinfo has launched a new service, in cooperation with UBS Global Wealth Management, that enables fund providers to publish fund-specific news in an automated and systematic way. The new service, known as News Dissemination, allows fund managers to provide their insights on the impact of recent market or political event – information not typically available in most fund documents. It is fully integrated into UBS's client-facing applications such as UBS eBanking, UBS Quotes, and Wealth Management Online (WMO). The service can also be integrated by other distributors. The easy-to-manage service, allows fund managers to create, edit and archive their news via a web-based fundinfo content management system, giving them complete control at all times. "This is a game changer. It's the first time fund providers have the opportunity to deliver ad-hoc and near real-time insights on t