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Lokelma approved in China for hyperkalaemia
Lokelma approved in China for hyperkalaemia.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 8101Y AstraZeneca PLC 06 January 2020 \n\n6 January 2020 07:00 GMT\n \nLokelma approved in China for the treatment\nof adult patients with hyperkalaemia\n \nPatients in China will benefit from Lokelma's rapid reduction\nof potassium in the blood and the sustained treatment effect\n \nAstraZeneca'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).\n \nThe 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.\n \nIn 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.\n \nMene 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.\"\n \nThe 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.1-3 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.1,2,4 Lokelma was well tolerated, with few serious adverse events.2\n \nLokelma 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.\n \nHyperkalaemia\nHyperkalaemia is characterised by high level...