ZS Pharma became a subsidiary of AstraZeneca in 2015 through a $2.7bn deal that saw the Anglo-Swedish Big Pharma firm add late-stage potassium-binding compound ZS-9 (sodium zirconium cyclosilicate) as a potential treatment for hyperkalaemia, a condition associated with chronic kidney disease (CKD).
The candidate, tipped to be a blockbuster product for AstraZeneca, has experienced several setbacks. A US Food and Druga Administration (FDA) preapproval inspection of ZS’s facility in Coppell, Texas resulted in a complete response letter (CRL) in May 2016, and a subsequent inspection in 2017 resulted in another regulatory rejection.
But during a conference call last week to discuss end-of-year results, AstraZeneca said it has “encouraging news for ZS-9 in both the US and EU,” something a spokesperson later told this publication included a decision by the US Food and Drug Administration (FDA) expected in the first half of this year.
According to AstraZeneca, the firm has addressed deficiencies identified during previous inspections of the dedicated active pharmaceutical ingredient (API) manufacturing facility, highlighted in a FDA Form 483 with five observations dated January 2017.
The redacted form can be found below.
The spokesperson also told us the European Medicines Agency (EMA) had recently re-adopted a positive opinion of the candidate.
The EMA first recommended approval of the drug in February 2017 under the name Lokelma, but the Agency’s Committee for Medicinal Products for Human Use (CHMP) reconfirmed last month after “an inspection of the manufacturing site for Lokelma’s active substance confirming that the site is compliant with good manufacturing practice.”