March 22, 2017
UK pharmaceutical giant AstraZeneca Plc (LON:AZN) said on Friday that the US Food and Drug Administration has refused to approve for the second time the hyperkalaemia medicine ZS-9 (sodium zirconium cyclosilicate) for manufacturing reasons.
Hyperkalaemia is a condition of high potassium levels in the body caused by metabolic, heart or kidney diseases. According to AstraZeneca, it occurs in between 23% and 47% of patients suffering from chronic kidney disease or chronic heart failure.
The company said that the rejection followed an inspection by the FDA of the ZS-9 manufacturing facility. The agency did not require new clinical data for the medicine.
ZS-9 was already turned down by the FDA in May 2016 due to a manufacturing issue but AstraZeneca resubmitted its application in October.
The company said that it is confident in its medicine and will be working with the US agency to resolve the remaining matters.
AstraZeneca obtained the drug after it acquired US biopharmaceutical company ZS Pharma for USD 2.7 billion (EUR 2.51bn) in 2015. The UK drug maker hoped to get a good share of the USD-6-billion hyperkalaemia market.
While AstraZeneca is trying to sort out its manufacturing issues, rival company Relypsa is already marketing its hyperkalaemia drug Veltassa (patiromer) in the USA. The medicine became part of Swiss Galenica's portfolio after Relypsa was acquired for USD 1.53 billion in September 2016.
According to earlier statements of AstraZeneca, ZS-9 is expected to reach peak global sales of over USD 1 billion annually. Despite the US problems, the medicine was recommended for EU approval by an advisory committee in February.
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