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AstraZeneca receives approval in Europe for hyperkalemia drug
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Two years after the FDA turned down an application for its hyperkalemia drug ZS-9, AstraZeneca announced on March 22 that it has received approval for the drug from the European Commission under its new name, Lokelma. AstraZeneca said in a press release that it hopes to get U.S. approval for the drug later this year.
The company paid $2.7 billion for ZS Pharma in November 2015 to gain access to ZS-9 and compete with Relypsa’s Veltassa, which received FDA approval in October of that year. In May 2016, the FDA rejected the application for ZS-9, citing manufacturing-related issues. AstraZeneca said the problems were not related to the clinical trials.
“The [complete response letter] refers to observations arising from a pre-approval manufacturing inspection,” the drugmaker said in a statement at the time.
AstraZeneca said the current E.U. approval of Lokelma (sodium zirconium cyclosilicate) is supported by data from three double-blind, placebo-controlled trials and one open-label trial, in which patients with hyperkalemia were treated for up to 12 months. In these trials, the median time to achieving normal potassium levels in the blood for patients receiving Lokelma was 2.2 hours, with 98% achieving normal levels within 48 hours from baseline, according to the release. Lokelma also demonstrated sustained potassium control for up to 1 year.
Elisabeth Björk, vice president and head of Cardiovascular, Renal and Metabolism, Global Medicines Development for AstraZeneca, said, “Today’s approval of Lokelma addresses a significant unmet need by bringing a rapid and sustained therapeutic option for patients with hyperkalemia.”
The risk of hyperkalemia increases significantly for patients with chronic kidney disease and for those who take common life-saving medications for heart failure, such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood, according to the release. To help prevent the recurrence of hyperkalemia, RAAS-inhibitor therapy is often modified or discontinued, but this can compromise cardio-renal outcomes and increase the risk of death.
References:
www.astrazeneca.com/media-centre/press-releases/2018/lokelma-approved-in-the-eu-for-the-treatment-of-adults-with-hyperkalaemia-22032018.html
www.nephrologynews.com/fda-rejects-astrazenecas-hyperkalemia-drug-application-due-manufacturing-issue/