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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-09T18:00:17+05:30 | Updated On 21 March 2024 9:17 PM IST

CDSCO panel approves protocol amendment of DATODXT study

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

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751