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
    • Latest News
    • GSK's severe pediatric...

    GSK's severe pediatric asthma drug wins European panel thumbs-up

    Written by Ruby Khatun Khatun Published On 2018-07-30T10:00:03+05:30  |  Updated On 17 Aug 2021 11:46 AM IST

    GlaxoSmithKline (GSK) drug Nucala has won a key recommendation from a European Medicines Agency (EMA) panel for use in the treatment of children with severe asthma, the company said in a statement on Friday.


    The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended Nucala for use as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients aged six up to 17 years, it said.


    While final approvals are up to the European Commission, it generally follows the CHMP's recommendation and endorses them within a couple of months.


    If approved, Nucala - chemically known as Mepolizumab - would be the first targeted biologic therapy for the treatment of severe eosinophilic asthma in pediatric patients in Europe, GSK said.


    A U.S. Food and Drug Administration expert panel on Wednesday did not support approval of Nucala in treating a disease that limits airflow to the lungs.


    The panel found that the drug, which is already approved for treating severe asthma patients, was safe but that it did not demonstrate efficacy for a new indication. FDA staff reviewers earlier raised doubts as to whether the data GSK submitted provided evidence of the drug's efficacy.


    GSK said then that it would work with the agency to address its concerns.


    The FDA is reviewing Nucala for reducing a sudden worsening of symptoms of chronic obstructive pulmonary disease, or COPD. While the FDA is not obliged to follow the advice of its experts, it generally does.






    (Reporting by Noor Zainab Hussain in Bengaluru; Editing by Jan Harvey)


    asthmaCHMPChronic Obstructive Pulmonary DiseaseCommittee for Medicinal Products for Human UseCOPDEMAEuropean CommissionEuropean Medicines AgencyFDAGlaxoSmithKlineGSKkey recommendationmepolizumabNucalarefractory eosinophilic asthma
    Source : REUTERS

    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

    Ruby Khatun Khatun
    Ruby Khatun Khatun
      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
      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. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok