AstraZeneca hit with second blow on $2.7 billion drug

pharmafile | March 17, 2017 | News story | Medical Communications AstraZeneca, FDA, hyperkalaemia 

AstraZeneca paid $2.7 billion for ZS Pharma, back in 2015, with the desire to get its hands on the company’s hyperkalaemia drug, ZS-9. AstraZeneca believes that the drug could become its next blockbuster, predicting that sales will go beyond $1 billion per year. However, the drug has been hit by its second rejection by the FDA.

AstraZeneca will be frustrated by the development but are confident that the issue can be resolved. This comes despite a previous rejection in May 2016 that saw the drug knocked back over manufacturing issues and it looks like the same problems have held back approval again.

“The CRL followed an inspection by the FDA of the ZS-9 manufacturing facility. The CRL does not require the generation of any new clinical data. AstraZeneca and ZS Pharma are committed to working with the FDA to resolve the remaining matters under review as soon as possible,” AstraZeneca released in a statement.

The treatment itself manages the potassium levels of patients with hyperkalaemia, a condition that is characterised by individuals with high levels of potassium in the blood. The condition is relatively common but can, in severe cases, lead to cardiac arrest and death.

The news does mean that AstraZeneca’s drug will far further behind Veltassa, by Relypsa, a rival treatment for hyperkalaemia that was approved by the FDA in October 2015.

The only piece of good news for AstraZeneca on the drug came last month, as it received a positive recommendation from the Committee for Medicinal Products for Human Use.

Ben Hargreaves

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