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FDA Sends Complete Response Letter To AstraZeneca PLC (ADR) (AZN) Following Rejection Of Hyperkalemia Drug

AstraZeneca PLC (ADR) (NYSE:AZN) has acknowledged the receipt of the Complete Response Letter (CRL) from the U.S. Food and Drug Administration for ZS-9, a drug designed to treat hyperkalemia. This is a condition where patients have a high level of potassium in their blood serum. In the United States, a CRL basically lists the conditions and concerns that need addressing before the FDA can grant approval for a drug candidate.

Manufacturing Facilities

Though AstraZeneca PLC (ADR) (NYSE:AZN) is not required to generate new clinical data, the Food and Drug Administration will yet again inspect the London, UK-based pharmaceutical firm’s manufacturing facility as part of efforts to work out pending issues in order to get approval for ZS-9. AstraZeneca is, however, not giving up in its efforts to get ZS-9 approved by the Food and Drug Administration.

“AstraZeneca remains dedicated to developing and commercialising sodium zirconium cyclosilicate for patients with hyperkalaemia, and is confident in the profile of this potential medicine. AstraZeneca and ZS Pharma are committed to working with the FDA… ” AstraZeneca said in a press release.

With the drug candidate having been rejected after its manufacturing facility had been inspected, it is believed the problem lies in production, which AstraZeneca PLC (ADR) (NYSE:AZN) will have to fix prior to seeking consideration for approval.

ZS Pharma Acquisition

The hyperkalemia treatment became part of AstraZeneca’s portfolio after ZS Pharma was acquired by the pharmaceutical giant towards the end of 2015 for a price of $2.7 billion.

Despite AstraZeneca’s best efforts, approval for ZS-9 has, however, proved elusive so far. But while the Food and Drug Administration has rejected ZS-9 for the second time now (with the first time being in May 2016), the hyperkalemia treatment has received approval from the European Union’s Committee for Medicinal Products for Human Use.

Prior to seeking approval last year, ZS-9 had been put under three double-blind trials which were placebo-controlled. There had also been an open label trial for 12 months in participants who were suffering from hyperkalemia.

In Monday’s trading session, shares of AstraZeneca PLC (ADR) (NYSE:AZN) edged up by 0.03% to close the day at $30.70.

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Note: This article is written by Andy Parker and was originally published at Market Exclusive.