AstraZeneca Resolves Mfg Issues for Potential Blockbuster Hyperkalemia Drug
AstraZeneca has resolved manufacturing issues at its manufacturing facility in Coppell, Texas for its investigational drug, ZS-9 (sodium zirconium cyclosilicate), a drug for treating hyperkalemia (high potassium levels in the blood serum). The company expects a regulatory decision for approval in 2018. AstraZeneca projected global peak year sales of ZS-9 to exceed $1 billion after it gained the drug from its $2.7-billlion acquisition of ZS Pharma, a San Mateo, California-headquartered biopharmaceutical company, in December 2015.
AstraZeneca received two Complete Response Letters (CRLs) from the US Food and Drug Administration for manufacturing issues at the Coppell facility, which it gained with the acquisition of ZS Pharma. The first was in May 2016 as a result of observations arising from a pre-approval manufacturing inspection of ZS-9. The second CRL was in March 2017.
The FDA now has accepted the Class II regulatory resubmission for ZS-9 following the progress AstraZeneca made in addressing the deficiencies identified during previous inspections of its manufacturing facility in Texas. AstraZeneca reported the update in its 2017 earnings report, which was released on February 2, 2018.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reiterated its previous positive opinion and recommended granting marketing authorization for ZS-9 in the European Union for treating hyperkalemia. A positive opinion was provided in February 2017; the opinion was, however, suspended following concerns relating to the cited 2016 manufacturing deficiencies. On the basis of recent inspection findings, the CHMP reiterated its original opinion in January 2018 by recommending marketing authorization.
ZS-9 is an insoluble, non-absorbed compound with a structure that is designed to preferentially trap potassium ions, according to information from AstraZeneca. The potassium selectivity of sodium zirconium cyclosilicate is expected to enable high in-vitro binding capacity for potassium ions even in the presence of other competing ions.