The Subject Expert Committee (SEC), which advises the national drug regulator on drug approvals and clinical trials, has recommended the grant of permission to drug major AstraZeneca for the import and marketing of two strengths of anti-hyperkalemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).
The company presented the proposal for a grant of permission to import and market Lokelma 5 g and 10 g, along with justification for a clinical trial waiver before the Committee.
The Committee for the 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 for the drug in the country.
The Committee, following this, recommended a grant of permission to import and market the drug with the condition that the firm should conduct a 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-hyperkalemia (HK) therapy that provides rapid potassium reduction and sustained potassium control. Hyperkalemia (HK) can be a chronic condition characterized by high levels of potassium in the blood, generally defined as greater than five mmol/L.
Patients with high potassium levels are at significant risk of cardiac arrhythmias, which can lead to cardiac arrest. The company, at the beginning of December 2023, said that worldwide, about 840 million and 64 million people are 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 hemodialysis. It is administered orally and is odorless, tasteless, and stable at room temperature. The drug has been approved in countries such as the United States, the European Union, China, and Japan.
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