The issue involves the conversion of the active pharmaceutical ingredient (API) to the finished drug product at its contract manufacturer. This has led to variable production yields of the finished drug product and Keryx has exhausted its reserve. The current stock of Auryxia is not sufficient to provide uninterrupted patient access to this drug and so Keryx is working with its manufacturers to resolve this issue and restore adequate supply.
Auryxia, a phosphate binder, was approved by the Food and Drug Administration (FDA) in September 2014 for the control of serum phosphorous levels in patients with chronic kidney disease (CKD) on dialysis. It works by binding with dietary phosphate in the gastrointestinal tract and precipitating as ferric phosphate. Unbound Auryxia has shown to increase serum iron parameters, including ferritin and transferrin saturation.
Auryxia is available as 210mg strength tablets and are expected to be available again during the 4th quarter of 2016.
For more information call (800) 307-6627 or visit Auryxia.com.