European regulators offer positive opinion on AstraZeneca drug that treats kidney, heart failure conditions
AstraZeneca announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the approval of ZS-9 for the treatment of hyperkalaemia.
The serious condition is characterized by high potassium levels in the blood serum caused by cardiovascular and kidney diseases.
Results from a late phase study showed that in patients with hyperkalaemia, using the medicine significantly reduced blood serum potassium to normal levels within 48 hours, with levels maintained during 12 days of maintenance therapy.
The condition occurs in 23 to 47 percent of patients with chronic kidney disease and chronic heart failure, both key strategic areas of focus for AstraZeneca.
The opinion will now be advanced to the European Commission (EC) for adoption of a decision on EU-wide marketing authorization of the medicine. The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.
Sodium zirconium cyclosilicate is being developed by ZS Pharma, a subsidiary of AstraZeneca. It is currently also under regulatory review in Australia and by the FDA in the US, with decisions expected in the first half of 2017.
AstraZeneca employs 1,500 people in Delaware.
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