AstraZeneca calls off two late-stage potassium drug trials
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca has been granted Fast Track Designation in the United States (US) for the development of LOKELMA® (sodium zirconium cyclosilicate) to reduce arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia (HK). The designation is based on the potential of LOKELMA to reduce serious adverse CV outcomes in this patient population, addressing a significant unmet medical need. This is being investigated in the ongoing Phase III DIALIZE-Outcomes trial.
The National Medical Products Administration (NMPA) has approved a dosing label update in China for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include patients with hyperkalaemia on chronic haemodialysis.
European regulators have approved a label update for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalaemia in patients with end-stage renal disease on stable haemodialysis.
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 hyperkalaemia in patients with end-stage renal disease on chronic haemodialysis.
sodium zirconium cyclosilicate
Preliminary guidelines released by the National Institute for Health and Care Excellence do not recommend NHS funding for hyperkalaemia treatments Lokelma and Veltassa.
AstraZeneca has picked up FDA approval for its hyperkalaemia treatment Lokelma, allowing it to compete head-to-head with rival Vifor Pharma on both sides of the Atlantic.
AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.3
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