Keryx: FDA OKs Auryxia Tablets For Iron Deficiency Anemia With CKD

(RTTNews) - Keryx Biopharmaceuticals, Inc. (KERX), a company focused on kidney disease, announced Tuesday that the U.S. Food and Drug Administration has approved Auryxia for an additional indication. The approval is for the treatment of iron deficiency anemia in adults with chronic kidney disease or CKD, not on dialysis.

Auryxia was originally approved in September 2014 for the control of serum phosphorus levels in people with chronic kidney disease who require dialysis.

With the new indication, millions of people living with chronic kidney disease have the potential to benefit from treatment with Auryxia. This medication is available in pharmacies and covered broadly by Medicare Part D and commercial insurance providers in the United States.

The company noted that Auryxia is the only oral treatment option available currently developed and approved specifically for adults living with iron deficiency anemia and chronic kidney disease, not on dialysis.

Auryxia's supplemental new drug application or sNDA approval was based on results from a 24-week placebo controlled Phase 3 clinical trial in 234 adults with stage 3-5 non-dialysis dependent chronic kidney disease.