Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • News
    • pharma-news
    • EMA accepts GSK filing...

    EMA accepts GSK filing for Trelegy Ellipta use in adults with asthma

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-03-04T10:15:00+05:30  |  Updated On 4 March 2020 4:45 AM GMT
    EMA accepts GSK filing for Trelegy Ellipta use in adults with asthma

    once-daily single inhaler triple therapy available for asthma and COPD if approved

    GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) has announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency (EMA).

    The submission is supported by the pivotal Phase III clinical study (CAPTAIN), conducted in 2,436 adult asthma patients across 15 countries whose disease remained inadequately controlled despite treatment with a combination of an inhaled corticosteroid and a long-acting β2-agonist (ICS/LABA). The study met its primary endpoint, demonstrating a statistically significant improvement in lung function compared with the ICS/LABA, Relvar/Breo Ellipta.

    There is currently no single inhaled triple therapy available for the treatment of asthma in Europe. Asthma, a chronic lung disease that inflames and narrows the airways, affects 358 million people worldwide. Even when adherent to ICS/LABA treatment, at least 30% of asthma patients continue to experience symptoms, indicating that they require further treatment.

    Trelegy Ellipta was approved in the European Union in November 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) who are not adequately treated by an ICS/LABA combination, or a combination of LABA and long-acting muscarinic antagonist (LAMA). If approved this would be the once-daily single inhaler triple therapy available for asthma and COPD.

    Read also: GSK India to sell Vemgal facility

    Regulatory applications have also been submitted for the Trelegy duplicate licences, Elebrato Ellipta and Temybric Ellipta. Submissions for the use of Trelegy Ellipta for the treatment of adult asthma patients were accepted for filing in the US by the FDA in December 2019 and in Japan by the Ministry of Health, Labour and Welfare in November 2019, and these regulatory review processes are ongoing.

    Medical Dialogues has previously reported drug firm GlaxoSmithKline Pharmaceuticals recently reported a consolidated net loss of Rs 661.16 crore for the December 2019 quarter, mainly on account of financial impact related to the voluntary recall of Zinetac.

    Read also: GSK India To Sell Vemgal Facility

    glaxosmithkline innoviva trelegy-ellipta fluticasone-furoate asthma ema gsk 

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier

      This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information:

      Search only trustworthy HONcode health websites:

      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2020 Minerva Medical Treatment Pvt Ltd

      © 2020 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      X