LOKELMA US Label Updated to Include Dosing Guidance for the Treatment of Hyperkalemia in Patients With End-Stage Renal Disease on Hemodialysis
AstraZeneca PLC - American Depositary Shares (AZN)
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Source: Business Wire
Label update is based on data from Phase IIIb DIALIZE trial WILMINGTON, Del.--(BUSINESS WIRE)--Today, the US Food and Drug Administration (FDA) approved a label update in the US for AstraZeneca’s LOKELMA® (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalemia in patients with end-stage renal disease on chronic hemodialysis.The approval by the US FDA was based on positive results from the Phase IIIb DIALIZE trial, the first ever randomized, placebo-controlled trial to evaluate a potassium binder in patients on stable hemodialysis. The DIALIZE trial showed that a significantly higher proportion of patients in the LOKELMA group (41.2%) met the primary endpoint and were classified as responders (maintained serum potassium 4-5 mmol/L during at least three out of four hemodialysis sessions after the long interdialytic interval [LIDI] of the last four weeks of treatment and did not require urgent rescue therapy) compared to patients in the placebo
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