Keryx Biopharmaceuticals (NASDAQ:KERX) a biopharma firm focused on bringing innovative drugs to people with renal disease, reported that the country’s leading Medicare Part D plan sponsor added Auryxia® to its Medicare Part D program formularies, effective immediately. The drug, Auryxia is presently indicated in the United States for the check on serum phosphorus levels in patients with chronic kidney disease on dialysis. Addition to Part D program formularies considerably extends unrestricted access to Auryxia for patients on dialysis and their caregivers.
Greg Madison, the CEO and President of Keryx, reported that they are delighted that another leading insurance provider has identified the value of Auryxia for patients. The addition to formularies, which comprise both this year and 2018, will boost continuing development of Auryxia in dialysis and ensuring that they can offer broad access to Auryxia for patients with iron deficiency anemia and non-dialysis dependent CKD, awaiting approval of this indication in this year.
It is projected that there are almost 450,000 people in the United States who suffered from End Stage Renal Disease and who needed dialysis treatment. The majority of ESRD subjects need chronic therapy with phosphate-binding drugs to reduce and maintain serum phosphorus at permissible levels. Commercial insurance companies and Medicare Part D cover a big part of the prescription costs for patients with ESRD, including the huge majority of phosphate binder prescriptions.
Keryx is looking for a label extension for ferric citrate to include the cure of iron deficiency anemia in people with non-dialysis dependent CKD. An add-on NDA is under review by the FDA, with a PDUFA target action date in November 2017 for completion.
Auryxia was approved by the U.S. FDA on September 5, 2014 and is permitted in the United States for the control of serum phosphorus levels in people with CKD on dialysis. This FDA approval of Auryxia came on data reported from the firm’s Phase III registration plan in dialysis patients.