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SEC recommends approval for Astrazeneca’s anti-hyperkalaemia drug Lokelma in India

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

The company presented the proposal for grant of permission to import and market Lokelma 5 g and 10 g along with justification for clinical trial waiver before the committee.

The Committee, for cardiovascular segment, in a meeting held on February 20, discussed the application and noted that the drug is approved in around 60 countries and there is an unmet medical need in the country for the drug.

The committee, following this, recommended grant of permission to import and market the drug with the condition that the firm should conduct phase IV clinical trial for which the protocol should be submitted within three months of approval of the drug for review by the SEC.

According to the company, Lokelma is an anti-hyperkalaemia (HK) therapy that provides rapid potassium reduction and sustained potassium control. Hyperkalemia (HK) can be a chronic condition characterised by high levels of potassium in the blood, generally defined as greater than 5 mmol/L. 

Patients with high potassium levels are at significant risk of cardiac arrhythmias, which can lead to cardiac arrest. The company, in the beginning of December, 2023, said that worldwide there are about 840 million and 64 million people living with CKD and HF respectively, who are at an estimated two to three times higher risk of hyperkalemia.

The drug is indicated for the treatment of HK in adults, including patients with end-stage kidney disease (ESKD) on chronic haemodialysis. It is administered orally and is odourless, tasteless, and stable at room temperature. The drug has been approved in countries including the US, European Union, China and Japan.

In December, 2023, the company announced that it has decided to discontinue two late-stage trials on the drug due to substantially increased enrollment timelines and low event rates, which has “made it prohibitive to deliver study results within a timeframe to meaningfully advance clinical practice”.

“The decision to discontinue the trials is not due to safety concerns and the positive benefit-risk of Lokelma does not change in the approved indication,” said the company.

These trials were part of the Crystalize evidence programme, which includes clinical and real-world evidence studies researching the potential benefit of Lokelma in the management of hyperkalaemia (HK) across the cardiorenal spectrum.

Sharon Barr, executive vice president, BioPharmaceuticals R&D Astrazeneca said: “Our ambitious CRYSTALIZE programme continues to generate evidence to improve the current management of hyperkalaemia, which we believe leads to better outcomes for cardiorenal patients when a potassium binder is included in their treatment regimen. Lokelma is the leading branded potassium binder globally and continues to benefit a broad hyperkalaemia patient population to achieve rapid, sustained potassium control and is well tolerated.”

The company will work with investigators to ensure the necessary follow-up with patients, it added.