AstraZeneca gets CDSCO Panel Nod To Import, Market Sodium Zirconium Cyclosilicate Powder for Oral Suspension

New Delhi: Noting an unmet medical need, the Subject ExperCommittee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major AstraZeneca to import and market Sodium Zirconium Cyclosilicate powder for oral suspension (Lokelma 5g and 10g).

However, this approval is subject to a condition that the drug major AstraZeneca should conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug.

This nod came after AstraZeneca presented the proposal for a grant of permission to import and market Sodium Zirconium Cyclosilicate powder for oral suspension 5g & 10g along with justification for a clinical trial waiver before the committee.

Sodium zirconium cyclosilicate is in a class of medications called potassium-removing agents. Sodium zirconium cyclosilicate is used to treat hyperkalemia (high potassium in the blood). This medicine is a potassium binder. It should not be used as an emergency treatment for life-threatening hyperkalemia. This medicine is available only with your doctor’s prescription.

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 Cardiovascular held on 20th February 2024, the expert panel reviewed the proposal presented by the drug major AstraZeneca to import and market Sodium Zirconium Cyclosilicate powder for oral suspension 5g and 10g along with justification for clinical trial waiver.

After detailed deliberation, the committee noted that the drug is approved in around 60 countries and there is an unmet medical need.

In view of the above, the expert panel recommended a grant of permission to import and market Sodium Zirconium Cyclosilicate Powder for Oral Suspension (Lokelma 5g and 10g) with the condition that the firm should conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.

Also Read:CDSCO Panel rejects Torrent proposal To Waive BE Study of FDC Gabapentin plus Duloxetine