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Lokelma approved in Japan for hyperkalaemia
Lokelma approved in Japan for hyperkalaemia.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 6832H\n AstraZeneca PLC\n 26 March 2020\n \n \n \n 26 March 2020 07:00 GMT\n \n \n \n Lokelma\n \n \n approved in Japan for the treatment of hyperkalaemia\n \n \n \n \n \n \n Patients in Japan will benefit from Lokelma's rapid and sustained potassium control\n \n \n \n \n \n AstraZeneca's Lokelma (sodium zirconium cyclosilicate) has been approved in Japan for the treatment of patients with hyperkalaemia (elevated levels of potassium in the blood).\n \n \n \n \n \n The approval \n by \n Japan's Ministry of Health, Labour and Welfare\n \n was based on positive results from stand-alone studies in Japan and global clinical trial programmes. It was also supported by DIALIZE, a global trial for\n \n \n end-stage renal disease patients on \n haemodialysis, which demonstrated the positive efficacy and safety of Lokelma in \n the management of\n \n hyperkalaemia.\n \n \n \n \n \n \n Lokelma\n \n is the first innovative non-resin potassium binder to be approved in Japan. Traditional resin-based binders are often associated with poor tolerability.\n \n \n \n \n \n Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: \"More than 300,000 patients in Japan suffer from hyperkalaemia, typically as result of chronic kidney disease or as a side effect from medications for heart failure. This approval ensures that this broad patient population,\n including those suffering from hyperkalaemia and patients with hyperkalaemia on stable haemodialysis, can benefit from Lokelma's rapid, sustained potassium control and tolerability.\"\n \n \n \n \n The global clinical trial programme showed that for patients receiving Lokelma, for up to 12-months in duration, 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.1Lokelma 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.2,3 In the DIALIZE trial, Lokelma demonstrated significantly improved control of pre-dialysis hyperkalaemia compared with placebo.4Lokelma was well tolerated, with few serious adverse events.3,4 Results in Japanese patients were broadly consistent with those seen in the global programme.\n \n \n \n \n...