AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA

pharmafile | May 27, 2016 | News story | Medical Communications, Research and Development AstraZeneca, NDA, US FDA, regulation 

UK pharma firm AstraZeneca (LSE: AZN) on Friday said the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding its new drug application (NDA) for the drug candidate to treat hyperkalaemia.

The CRL refers to observations arising from a pre-approval manufacturing inspection. The drug is being developed by ZS Pharma, a unit of AstraZeneca.

The FDA also acknowledged receipt of recently-submitted data which it has yet to review. The CRL does not require the generation of new clinical data. AstraZeneca and ZS Pharma are evaluating the content of the CRL and will work closely with the FDA to determine the appropriate next steps for the NDA, the company said in a statement.

The company said the drug is targeted at treating a condition called hyperkalaemia or high potassium levels in the blood serum.

Hyperkalaemia occurs in 23-47% of patients with advanced chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death (mortality of up to 30% in patients with severe hyperkalaemia if not treated rapidly). Treatment with common heart medicines (RAAS inhibitors) can also be responsible for increases in hyperkalaemia.

Anjali Shukla

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