US regulator, the Food and Drug Administration, has agreed to review the application, which indicates that the application is sufficiently complete to permit a substantive review.
The target date for the FDA to complete its sNDA review is 6 November, 2017.
Auryxia (ferric nitrate) is currently approved for use in the US for the control of serum phosphorus levels in patients with end-stage renal disease requiring dialysis.
“Iron deficiency anemia is a common complication in people with non-dialysis dependent chronic kidney disease, yet currently there are no FDA-approved oral medicines to treat this debilitating disease,” said John Neylan, chief medical officer at Keryx.
“Acceptance of the sNDA filing not only brings us one step closer to providing this medicine to patients in need; it is an important milestone for the company and our efforts to leverage ferric citrate’s mechanism of action.”
The sNDA was based on data from a 24-week placebo controlled Phase 3 trial in 234 adults.
Story by ProactiveInvestors