CDSCO Panel grants AstraZeneca's Protocol Amendment Proposal for Sodium zirconium cyclosilicate
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment request presented by drug major AstraZeneca Sodium zirconium cyclosilicate.
This came after the firm presented Protocol amendment version 3.0 dated 04 Apr 2023 Protocol no. D9487C00001. The study is to evaluate the effect of Sodium Zirconium Cyclosilicate on Arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.
Sodium zirconium cyclosilicate is a potassium binder used to treat hyperkalemia.
Hyperkalemia is a condition defined by elevated potassium levels in the blood, often caused by cardiovascular, renal, and metabolic diseases. Hyperkalemia occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure and may lead to cardiac arrest and death.
Sodium zirconium cyclosilicate is subsequently a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations. Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations such as calcium and magnesium, in vitro. Sodium zirconium cyclosilicate captures potassium throughout the entire gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels and increasing fecal potassium excretion to resolve hyperkalemia.
At the recent SEC meeting for the Cardiovascular and Renal held on 28 November 2023, the expert panel reviewed the protocol amendment version 3.0 dated 04 Apr 2023 Protocol no. D9487C00001
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
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