FDA Roundup

Keryx Pharmaceuticals (Boston) announced that the US Food and Drug Administration (FDA) will review its drug Auryxia (ferric citrate) for use in patients who have iron deficiency anemia and non-dialysis–dependent chronic kidney disease (CKD). Ferric citrate is a phosphate binder indicated for controlling serum phosphorus levels, typically in patients with CKD who are on dialysis.

A review for the new use of the drug should be complete by Nov. 6, 2017, according to Drugs.com.

The supplemental New Drug Application (NDA) is based on data from a 2-week controlled, phase 3 trial in 234 adults with non-dialysis–dependent CKD. Patients enrolled in the trial were intolerant to or had an inadequate response to previous treatment with oral iron supplements. Patients did not receive any intravenous or oral iron, or erythropoiesis-stimulating agents. In the study, treatment with Auryxia demonstrated significant increases in hemoglobin levels of >1 g/dL at any point during the 16-week efficacy period for the majority of patients (52.1%; n = 61/117), which was deemed a clinically meaningful result.

AstraZeneca received disappointing news from the FDA: a complete response letter regarding AstraZeneca’s NDA for ZS-9, sodium zirconium cyclosilicate. This is a second FDA rejection for the treatment, an insoluble, non-absorbed compound with a structure that was designed to preferentially capture potassium ions. The compound was initially rejected by the FDA in May 2016, “on the back of certain manufacturing issues,” Pharmatimes.com reported. The drug is being developed by ZS Pharma, a subsidiary of AstraZeneca.

The FDA also has offered nonbinding recommendations to the pharmaceutical industry about how to move forward in developing drugs that prevent delayed graft function after transplantation. An FDA guidance report recommends that trials for drugs to treat the condition should be an active treatment versus placebo design, because there is no approved drug for preventing delayed graft function. The FDA also recommended a preapproval safety database of 300 patients or more who are using the investigational drug. The Regulatory Affairs Professional Society noted that the trials should collect specific information on the type of donors (i.e., donation after brain death, cardiac death, or living donor), the type of organ recovery, organ storage and transport conditions, and post-transplantation immunosuppressive therapy used.

May 2017 (Vol. 9, Number 5)