ZS 9 is filed at FDA to treat hyperkalaemia- ZS Pharma
ZS Pharma, Inc. a biopharmaceutical company focused on the development and commercialization of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders, announced that it has submitted a New Drug Application (NDA) to the FDA for ZS-9 (sodium zirconium cyclosilicate). The NDA requests FDA approval of ZS-9 for the treatment of hyperkalaemia.
In top-line results from a 753-patient Phase III trial, the oral treatment met its primary endpoint of significantly lowering serum potassium levels with adverse events similar to placebo presenting a promising dose-dependent response for hyperkalaemia sufferers.
Comment: RLY 5016 ( patiromer) from Relypsa Inc. was filed at the FDA in October 2014 to treat hyperkalaemia.
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