Keryx Biopharmaceuticals (NASDAQ:KERX) announced on November 7 that the Food and Drug Administration (FDA) has approved its treatment called Auryxia for additional indication.
The drug has been approved for treating chronic kidney disease adult patients suffering from iron deficiency anemia. It is also noteworthy that the approval is for patients that are not on dialysis. Auryxia initially received FDA approval as a treatment used to control the levels of serum phosphorus in patients suffering from chronic kidney disease who also require dialysis.
Auryxia’s new indication will make it a viable treatment option for millions of patients living with chronic kidney disease. The treatment is already available in many pharmacies that are currently catered to by commercial insurance providers and Medicare Part D in the U.S.
“More than half of the approximate 30 million people in the United States living with chronic kidney disease are iron deficient, and yet, this is the only tablet that has been developed and approved specifically to address iron deficiency anemia in these patients, who are not on dialysis,” stated Dr. Steven Fishbane, the head of the hypertension and kidney diseases division at Northwell Health in Great Neck, New York.
Dr. Fishbane stated that the approval means physicians can now prescribe oral iron drugs to help patients who are currently living with the condition. He also pointed out that most of the patients that suffer from the chronic kidney disease do not receive optimal treatment. Dr. John Neylan, the senior VP and the head of chief medical officer at Keryx stated that his company was pleased with the fact that Auryxia received FDA approval. Neylan also added that the approval means patients and physicians have a new treatment option for managing chronic kidney disease and iron deficiency anemia.
The FDA approved the treatment based on the results of a Phase 3 clinical trial that lasted 24 weeks and involved 234 adult patients. The study had a placebo arm and the results were favorable, thus aiding in fueling the approval by the regulatory body.
Keryx stock closed the latest trading session on Tuesday at $5.15 after tanking by 17.34 percent compared to the value of the stock during the previous close.