The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of ZS-9 (sodium zirconium cyclosilicate).
The medicine is being developed by ZS Pharma, a subsidiary of AstraZeneca.
ZS-9 is for the treatment of hyperkalaemia, a condition that includes high potassium levels in the blood serum due to cardiovascular, renal and metabolic diseases.
The recommendation follows trials, including three double-blind placebo-controlled trials and one ongoing 12-month open-label trial, with over 1,600 adults who have hyperkalaemia.
Results from a Phase III study revealed that ZS-9 brought blood serum potassium down to normal levels within two days. During 12 days of maintenance therapy, levels remained normal.
Another study also achieved normal levels of blood serum potassium within 48 hours. Compared to a placebo, more patients maintained normal levels for up to 28 days during treatment.
In these trials, ZS-9 lowered serum potassium levels in patients with acute and chronic hyperkalaemia.
The Committee for Medicinal Products' recommendation will go to the European Commission for adoption of a decision on marketing authorization throughout the European Union. The decision will apply all 28 European Union member countries, as well as Iceland, Norway and Liechtenstein.
The medicine under review in the United States.
