AstraZeneca Pharma India Ltd has been granted regulatory approval by the Central Drugs Standard Control Organisation (CDSCO) to import and sell sodium zirconium cyclosilicate powder for oral suspension (Lokelma) in India. The drug is prescribed for the treatment of hyperkalaemia, a condition that is defined by high levels of potassium in the blood.

Key Highlights

• CDSCO Approval: AstraZeneca may import and distribute sodium zirconium cyclosilicate doses (5g and 10g) in India.

• Indication: The medicine is particularly approved for treating hyperkalaemia in adult patients.

• Next Steps: The firm will move forward with the statutory approvals necessary for commercial launch in India.

What is Hyperkalaemia?

• Hyperkalaemia happens when the levels of potassium in the blood become higher than they should be.

• It is life-threatening because increased potassium can result in abnormal heart rhythms, weak muscles, and heart failure.

About Sodium Zirconium Cyclosilicate (Lokelma)

• Lokelma is a potassium-binding medicine that reduces and controls normal potassium levels in adult patients with hyperkalaemia.

• It is given in the form of an oral suspension powder and works by selectively binding potassium ions in the gastrointestinal tract, blocking their entry into the bloodstream.

AstraZeneca's Statement
"The receipt of this permission opens the way for the launch of sodium zirconium cyclosilicate powder for oral suspension (Lokelma) in India for the above-stated indications, subject to the receipt of related statutory approvals," AstraZeneca Pharma India said in a regulatory filing.

Why This Matters?

• Met a Severe Medical Need: India experiences an increasing population of patients with chronic kidney disease (CKD), cardiovascular diseases, and metabolic syndrome, all of which are associated with hyperkalaemia.

• Improved Treatment Alternatives: Lokelma offers a safer, effective, and quick-acting potassium-reducing therapy, alleviating reliance on previous therapies.

• Strengthens AstraZeneca's India Portfolio: The approval enhances AstraZeneca's presence in India's nephrology and cardiology markets.

After receiving approval from CDSCO, AstraZeneca will launch Lokelma in India, thereby increasing the options for treating patients with hyperkalaemia. The launch is subject to other regulatory approvals. This move indicates the increasing attention towards sophisticated nephrology and electrolyte management solutions in India.