AstraZeneca has announced that it has received the approval for Lokelma (sodium zirconium cyclosilicate) in Japan.
Japan's Ministry of Health, Labour, and Welfare approved the drug based on the DIALIZE study, which demonstrated the efficacy and safety of Lokelma in patients suffering from hyperkalemia.
About DIALIZE study:
Phase IIIb trial investigated the efficacy of Lokelma in patients with end-stage renal disease (ESRD) on hemodialysis. The patients were randomized to receive a placebo and Lokelma. The treatment period was eight weeks.
41.2% of patients maintained normal potassium levels compared to 1% of patients who were on placebo.
Hyperkalaemia: Hyperkalaemia is characterized by elevated levels of potassium in the blood. Chronic kidney disease (CKD), heart failure (HF), and diabetes are the common co-morbidities associated with hyperkalemia. These are the conditions related to treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors. The company stated that Lokelma is the first innovative non-resin potassium binder approved in Japan.