First for Japan with the approval of AstraZeneca’s Lokelma in hyperkalaemia

pharmafile | March 26, 2020 | News story | Sales and Marketing AstraZeneca, Astra|Zeneca, Japan, Lokelma, hyperkalaemia, pharma 

Japan’s Ministry of Health, Labour and Welfare has awarded approval to AstraZeneca’s Lokelma for the treatment of hyerkalaemia, marking the first authorisation for an innovative non-resin potassium binder in the country.

Supporting data was generated from studies conducted in Japan and around the world.

According to AZ, the data illustrated the drug’s safety and efficacy in hyperkalaemia, a condition characterised by elevated potassium levels in the blood. Patients who take common heart failure meds, which can increase potassium levels in the blood, are at higher risk of the condition, as are those with chronic kidney disease.

These data showed that median time to reach normal blood potassium levels was recorded as 2.2 hours with Lokelma; 98% of patient receiving the drug achieved normal levels within 48 hours from baseline. The drug was also shown to reduce blood potassium levels in as little as one hour from one dose, with the effects maintained for up to a year.

In addition, Lokelma “significantly improved control of predialysis hyperkalaemia compared to placebo” in a global trial of patients with end-stage renal disease who are undergoing haemodialysis.

“More than 300,000 patients in Japan suffer from hyperkalaemia, typically as result of chronic kidney disease or as a side effect from medications for heart failure,” remarked Mene Pangalos, AZ’s Executive Vice President, BioPharmaceuticals R&D. “This approval ensures that this broad patient population, including those suffering from hyperkalaemia and patients with hyperkalaemia on stable haemodialysis, can benefit from Lokelma’s rapid, sustained potassium control and tolerability.”

With this latest approval, Lokelma is authorised for use in the US, EU, China, Russia, Canada, Hong Kong and Japan.

Matt Fellows

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