AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India to import pharmaceutical formulations of new drug for sale or distribution for Sodium Zirconium Cyclosilicate (SZC) powder – oral suspension 5 g and 10 g. This treatment can enhance the management of hyperkalaemia in adults, a condition characterised by elevated potassium levels that often accompanies cardiovascular, renal, and metabolic diseases.
Hyperkalaemia poses significant risks, primarily for patients with chronic kidney disease (CKD) and those on heart failure (HF) medication like renin-angiotensin-aldosterone system (RAAS) inhibitors, which can elevate potassium levels. Alarmingly, hyperkalaemia prevalence is noted in 50 per cent of CKD and 42 per cent of chronic HF patients. To prevent hyperkalaemia recurrence, RAAS-inhibitor therapy often needs modification or discontinuation, potentially compromising cardio-renal outcomes and increasing mortality risk. In India, hyperkalaemia-related mortality stands at 22.2 per cent. SZC stands to deliver a rapid, effective and generally well-tolerated treatment option to patients suffering from hyperkalaemia.
Dr Dinesh Khullar, Chairman – Nephrology and Renal Transplant Medicine Max Saket Complex Delhi, said, “When our patients on RAASi experience hyperkalaemia, we may face a dilemma of whether to accept the risk of hyperkalaemia that comes with continuing the guideline-recommended RAASi or to reduce or stop these medications, which would mean our patients are not receiving the proven clinical benefits of RAASi. SZC is a novel K+ binder that enables physicians to manage hyperkalaemia and thereby enable guideline-recommended RAASi treatment. SZC acts as a highly-selective potassium-removing agent and comes with an advantage of rapid onset of action, good efficacy and generally well-tolerated treatment option to patients suffering from hyperkalaemia.”
Dr Sanjeev Panchal, Country President and Managing Director AstraZeneca Pharma India, said, “The SZC approval is a significant milestone for us and will help strengthen our focus on specialist disease areas in our Biopharmaceutical portfolio.”
SZC, an insoluble, non-absorbed sodium zirconium silicate, is administered as an oral suspension. It is odourless, tasteless, and stable at room temperature. Clinical trials have demonstrated its effectiveness, with action onset in an hour and normalisation of potassium levels within 2.2 hours, achieved by 92 per cent of patients within just 48 hours, sustained over a 12-month period.