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
    • AstraZeneca Lokelma...

    AstraZeneca Lokelma gets Chinese approval for treating hyperkalaemia

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-01-07T09:30:28+05:30  |  Updated On 7 Jan 2020 9:30 AM IST

    New Delhi: AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) has been approved in China for the treatment of adult patients with hyperkalaemia (elevated levels of potassium in the blood).


    The approval by the National Medical Products Administration (NMPA) was based on positive results from the extensive Lokelma clinical trial programme and a pharmacodynamic study in China which showed that patients receiving Lokelma experienced a significant, rapid and sustained reduction of potassium in the blood.


    In 2019, the NMPA included Lokelma on the Accelerated Approval list of “Overseas New Drugs in Clinical Urgent Needs for China”, recognising the significant unmet need for effective medicines treating hyperkalaemia.


    Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “This approval marks an important milestone for more than two million patients in China who suffer from hyperkalaemia. Lokelma will offer the opportunity for patients and physicians to achieve long-term disease control and potentially reduce the risk of acute episodes, which can have serious, even life-threatening consequences.”


    Read Also: Drug developers including AstraZeneca, GSK take fresh aim at guided-missile cancer drugs: Report


    The Lokelma clinical trials programme includes three double-blinded, placebo-controlled trials and one open-label trial, where patients with hyperkalaemia were treated for up to 12 months. These trials showed that for patients receiving Lokelma, the median time to achieving normal potassium levels in the blood was 2.2 hours, with 98% achieving normal levels within 48 hours from baseline. Lokelma also demonstrated a rapid reduction of potassium in the blood as early as one hour with one dose and a sustained treatment effect for up to one year. Lokelma was well tolerated, with few serious adverse events.


    Lokelma is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing medicine. It is administered orally, is odourless, tasteless and stable at room temperature. It has been evaluated in three double-blinded, placebo-controlled trials and in one 12-month open-label trial in patients with hyperkalaemia.


    Lokelma is approved in the US, the EU and Canada for the treatment of hyperkalaemia. It is undergoing separate regulatory review in Japan, with a decision expected in the first half of 2020.


    Hyperkalaemia


    Hyperkalaemia is characterised by high levels of potassium in the blood (generally classified as >5mmol/l).1 The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure (HF), such as RAAS inhibitors, which can increase potassium in the blood. Hyperkalaemia occurs in 23% to 47% of patients with CKD and/or HF, with an estimated 200 million and 64 million people, respectively, living with each condition worldwide.5-7 Hyperkalaemia may lead to cardiac arrest and death, with mortality being up to 30% in patients with severe hyperkalaemia, if not treated rapidly.8


    Read Also: AstraZeneca CKD anaemia drug Roxadustat shows increased haemoglobin levels in Phase 3 trial

    AstraZenecachinaCKDhyperkalaemiaLokelmaNational Medical Products AdministrationNMPApharmapharma companypharma newspharmacodynamic studysodium zirconium cyclosilicate

    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
      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