AstraZeneca Secures CDSCO Approval to Import SZC for Hyperkalaemia

The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, has granted AstraZeneca Pharma India permission to import pharmaceutical formulations of new drugs for sale or distribution of oral suspensions containing 5 g and 10 g of sodium zirconium cyclosilicate (SZC) powder. Adult hyperkalaemia, a disorder marked by high potassium levels that frequently coexists with metabolic, renal, and cardiovascular disorders, can be better managed with this medication.Patients with chronic kidney disease (CKD) and those on heart failure (HF) medications such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can raise potassium levels, are particularly at risk for hyperkalaemia. It is concerning to see that 42% of patients with chronic heart failure and 50% of patients with CKD had hyperkalaemia. RAAS-inhibitor therapy frequently needs to be modified or stopped in order to prevent hyperkalaemia recurrence, which could jeopardize cardio-renal results and raise the risk of death. The mortality rate from hyperkalaemia is 22.2% in India. SZC has the potential to provide patients with hyperkalaemia with a quick, efficient, and usually well-tolerated therapy alternative.

“The SZC approval is a significant milestone for us and will help strengthen our focus on specialist disease areas in our Biopharmaceutical portfolio.” Dr Sanjeev Panchal, Country President and Managing Director AstraZeneca Pharma India, said.

Oral suspension is used to give sodium zirconium silicate (SZC), an insoluble and non-absorbed substance. It is stable at room temperature and has no taste or odor. It has been shown in clinical trials to be successful, with an hourly beginning of action and 2.2-hour potassium level normalization, which 92% of patients attain in under 48 hours and maintain over a 12-month period.