ViiV Healthcare Submits Regulatory Application to European Medicines Agency for Investigational Cabotegravir to Be Used in Combination With Rilpivirine as the First Monthly, Injectable Treatment for HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. The application also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy.
Deborah Waterhouse, CEO of ViiV Healthcare, said: “ViiV Healthcare is proud to be sending a regulatory submission to the EMA for what will be a first-of-its-kind treatment. If approved, this long-acting, injectable regimen of cabotegravir and rilpivirine has the potential to give people living with HIV one month between doses with similar safety and efficacy as today’s standard of care – an oral, 3-drug regimen taken every day. We are excited to be one step closer to delivering this long-acting therapy to patients in Europe.”
The submission is based on the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies that included more than 1,100 patients from 16 countries and demonstrated the combination of cabotegravir and rilpivirine, injected monthly, was as effective as a daily, oral, 3-drug regimen in maintaining viral suppression throughout the 48-week study period. The ATLAS and FLAIR studies are part of ViiV Healthcare’s innovative clinical trial programme for 2-drug regimens (2DRs).
Kimberly Smith, M.D., Head of Global Medical Research and Strategy at ViiV Healthcare, said: “This regulatory submission supports ViiV Healthcare’s commitment to developing new and innovative options for people living with HIV to manage their virus. We are proud to be at the forefront of this innovation for patients by potentially changing the frequency of therapy from 365 days per year to just 12.”
This application to the EMA follows the recent submission of a New Drug Application (NDA) for the 2DR of cabotegravir and rilpivirine, as well as cabotegravir oral tablets, to the US Food and Drug Administration (FDA) in April 2019. In June, this submission was granted a Priority Review Designation by the FDA with an expected action date of December 29, 2019. ViiV Healthcare and Janssen also plan to submit additional regulatory applications for cabotegravir and rilpivirine to other regulatory agencies in the coming months.
About ATLAS and FLAIR
ATLAS (NCT02951052) is a phase III, open-label, active-controlled, multicentre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a 2-drug regimen of long-acting, injectable cabotegravir and rilpivirine, dosed every four weeks, compared to continuation of current oral anti-retroviral therapy (ART) of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI) among virally suppressed individuals. The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population). Subjects were required to be virally suppressed for six months or greater, on first or second regimen, with no prior failure.
FLAIR (NCT02938520) is a phase III, randomised, open-label, multicentre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a 2-drug regimen of intramuscular, long-acting, injectable cabotegravir and rilpivirine in virologically suppressed adults living with HIV, following 20 weeks of induction therapy with Triumeq (abacavir, dolutegravir and lamivudine tablets). The primary endpoint for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population).
Cabotegravir is an investigational integrase inhibitor (INI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV. It is being evaluated as a long-acting formulation for intramuscular injection and also as a once-daily oral tablet for use as a lead-in, to establish the tolerability of cabotegravir prior to long-acting injection.
EDURANT® (rilpivirine) is a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35-kg with a viral load ≤ 100,000 HIV RNA copies/mL. Long-acting, injectable rilpivirine is not approved by regulatory authorities anywhere in the world.
Rilpivirine was developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Rilpivirine is approved in the US and EU as EDURANT® as a 25mg tablet taken once-a-day and is always taken with a meal. The most common side effects of EDURANT include: depression, headache, trouble sleeping (insomnia) and rash.
Important Safety Information (ISI) for EDURANT® (Rilpivirine)
Note: this is taken from the US label and local variations apply. Please refer to applicable local labelling.
About EDURANT® (Rilpivirine)
- EDURANT® (rilpivirine) is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older and who weigh at least 77 lbs (35 kg):
- Have never taken HIV medicines before, and
- Have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL
- EDURANT® is not recommended for patients less than 12 years of age or who weigh less than 77 lbs (35 kg)
IMPORTANT SAFETY INFORMATION
Who should not take EDURANT®?
Do not take EDURANT® if you also take:
anti-tuberculosis (anti-TB) medicines:
proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
- pantoprazole sodium
- more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
- St. John’s wort (Hypericum perforatum)
What should I tell my healthcare provider before taking EDURANT®?
Before taking EDURANT®, tell your healthcare provider about all your medical conditions, including if you:
- have or had liver problems, including hepatitis B or C virus infection
- have kidney problems
- have ever had a mental health problem
- are pregnant or plan to become pregnant. It is not known if EDURANT® will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with EDURANT®.
- are breastfeeding or plan to breastfeed. Do not breastfeed if you take EDURANT®.
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
- It is not known if EDURANT® passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during EDURANT® treatment.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT® with other medicines.
How should I take EDURANT®?
- Take EDURANT® every day exactly as your healthcare provider tells you to.
- Take EDURANT® 1 time each day with a meal. A protein drink alone does not replace a meal.
- Do not change your dose or stop taking EDURANT® without first talking with your healthcare provider. Stay under the care of your healthcare provider during treatment with EDURANT®.
- Do not miss a dose of EDURANT®.
- If you take an H2-receptor antagonist (famotidine, cimetidine, nizatidine, or ranitidine), you should take these medicines at least 12 hours before or at least 4 hours after you take EDURANT®.
- If you take antacids, or other products that contain aluminum, calcium carbonate, or magnesium hydroxide, you should take these medicines at least 2 hours before or at least 4 hours after you take EDURANT®.
- If you miss a dose of EDURANT® within 12 hours of the time you usually take it, take your dose of EDURANT® with a meal as soon as possible. Then, take your next dose of EDURANT® at the regularly scheduled time. If you miss a dose of EDURANT® by more than 12 hours of the time you usually take it, wait and then take the next dose of EDURANT® at the regularly scheduled time.
- Do not take more than your prescribed dose to make up for a missed dose.
- If you take too much EDURANT®, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of EDURANT®?
EDURANT® can cause serious side effects including:
- Severe skin rash and allergic reactions. Skin rash is a common side effect of EDURANT®. Skin rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital.
If you get a rash with any of the following symptoms, stop taking EDURANT® and get medical help right away:
- Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT®. Liver problems have also happened during treatment with EDURANT® in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with EDURANT®.
Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:
- feeling sad or hopeless
- feeling anxious or restless
- have thoughts of hurting yourself (suicide) or have tried to hurt yourself
- Changes in body fat can happen in people who take HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these problems are not known.
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
The most common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away. Do not stop taking EDURANT® or any other medications without first talking to your healthcare provider.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).
Please see accompanying full Product Information for more details.
Full US prescribing information including is available at:
For the EU Summary of Product Characteristics, please visit:
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 as a shareholder 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 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.
ViiV Healthcare Media enquiries:
Melinda Stubbee, +1 919 491 0831 (US)
Audrey Abernathy, +1 919 605 4521 (US)
GSK Global Media enquiries:
Simon Steel, +44 (0) 20 8047 5502 (UK)
Kristen Neese, +1 804 217 8147 (US)
Sarah Elton-Farr, +44 (0) 20 8047 5194 (UK)
Danielle Smith, +44 (0) 20 8047 0932 (UK)
James Dodwell, +44 (0) 20 8047 2406 (UK)
Jeff McLaughlin, +1 215 751 7002 (US)
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
Topcon to Attend EURETINA 2019 Meeting21.8.2019 07:00:00 EEST | Press release
Topcon Europe Medical, a leading provider of medical devices and software solutions for the European eye care community, is excited to announce its participation in EURETINA 2019, the European Society of Retinal Specialists’ annual congress, which has become internationally renowned as the largest retina meeting worldwide. On 5-8 September, thousands of vitreoretinal and macula specialists will gather at the Palais des Congrès de Paris in France to share information on the latest trends and advances in vitreoretinal surgery and the diagnosis and treatment of retinal diseases including macular degeneration and diabetic retinopathy. Topcon will be located in the Exhibit Hall, Level 2 at Booth #219 and will showcase its latest innovative technology solutions for today’s retina specialists including the Triton Swept Source OCT, the newly released Maestro Fully Automated OCT with Angiography, Artificial Intelligence systems, the all new Topcon Signal Hand-held Camera, and the PASCAL Laser S
IFF to Present at Barclays Global Consumer Staples Conference September 520.8.2019 23:15:00 EEST | Press release
Regulatory News: IFF (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent, and nutrition & ingredients today announced that the Company’s management will speak at the Barclays Global Consumer Staples Conference in Boston, Massachusetts, on Thursday, Sept 5, 2019 at 2:15 PM ET. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Welcome to IFF At IFF (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), we’re using Uncommon Sense to create what the world needs. As a collective of unconventional thinkers and creators, we put science and artistry to work to create unique and unexpected scents, tastes, experiences and ingredients for the products our world craves. Learn more at iff.com, Twitter , Facebook, Instagram, and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/ho
Novalis LifeSciences Launches its First Life Science Investment Fund with $85 Million20.8.2019 19:29:00 EEST | Press release
August 20th, 2019, Novalis LifeSciences, an investment and advisory firm for the Life Science industry, announced today that it has raised $85M in capital for its first fund - Novalis LifeSciences Investments I, L.P. Novalis LifeSciences is focused on highly innovative Life Science companies. On the occasion of closing the first fund, Marijn E. Dekkers, founder and chairman, said: “This first fund is a growth-oriented fund that will invest in 8-12 companies that are commercializing breakthrough technologies in various segments of the Life Science industry. This includes drug discovery, life science tools, genomics, synthetic biology, diagnostics, and agricultural biotechnology – all areas with huge unmet needs and exciting opportunities for investors”. About Novalis LifeSciences Novalis Lifesciences LLC, is a globally acting venture capital firm focused on breakthrough technologies in Life Science. Founded and managed by Dr. Marijn E. Dekkers, current chairman of Unilever and former ch
Bermuda Tech Week 2019 to Celebrate Innovation and Explore Opportunities for Growth20.8.2019 17:27:00 EEST | Press release
Registration is under way and filling fast for Bermuda Tech Week 2019 which will take place at the Hamilton Princess & Beach Club from October 14-18, 2019. The programme of insightful and engaging events will explore future opportunities and challenges presented by emerging technologies such as artificial intelligence, blockchain, digital assets, insurtech and virtual reality. It will showcase Bermuda’s ongoing success in creating a welcoming, stable and well-regulated environment where technology and start-up companies can thrive. “Bermuda has a long history of innovation so we understand and recognise the power of technology to positively impact both the economy and society,” said Bermuda Premier David Burt. “Over the past two years, we have built on our strength as a global leader in regulating the risks associated with the global insurance industry to develop a clear regulatory framework around managing the risks associated with Fintech. Our progressive approach has drawn accolades
Limelight Networks Expands Developer Toolkit With New API and Portal Enhancements20.8.2019 17:25:00 EEST | Press release
Limelight Networks, Inc. (Nasdaq: LLNW), a leading provider of edge cloud services, today announced it has expanded the management and configuration capabilities of its suite of services with new Application Programming Interfaces (APIs) and web portal offerings. With these new capabilities in addition to existing APIs and Software Development Kits, developers now have more power to manage and monitor services across Limelight’s edge cloud platform. According to an IDC surveyi, more than half the organizations surveyed have already adopted DevOps practices, with an additional 20 percent planning to do so in the next 12 months. To help organizations meet these demands, Limelight has introduced expanded API capabilities to provide developers with access to the full set of configuration options available across its content delivery services. Limelight’s new Configuration API enables developers to configure Limelight services and programmatically integrate them into their workflows. It exp
Andersen Global Enters Zimbabwe20.8.2019 16:30:00 EEST | Press release
Andersen Global announced it has signed a collaboration agreement with Chimwamurombe Legal Practice (Zenas) in Zimbabwe. Andersen Global has built a presence in over 14 African countries in just under two years. Zenas was founded in 2015 and now has a team of 11 professionals who provide legal services to individuals, organizations, institutions and corporations. With a specialty of serving small to medium enterprises, they offer solutions in mining and construction, commercial, debt recovery, property law, labor law, family law, tax, technology, telecommunications, media and intellectual property law, and criminal litigation. “When we started, we set out to be the most sought-after, trusted legal firm in Zimbabwe,” said Fungai Chimwamurombe, Zenas Office Managing Director. “These values line up very closely with those firms in the Andersen Global international organization. We are happy to join a team of professionals that is equally committed to treating clients like family and deliv
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