FDA gives a qualified 'yes' to Keryx's chronic kidney disease drug
- The FDA has approved ferric citrate (brand name Zerenex, although the company won’t be using that name) for the control of serum phosphorous levels in patients with chronic kidney disease (CKD) who are receiving dialysis treatment.
- The treatment results in increased iron levels, which should make patients less reliant on anemia treatments.
- The drug comes with a warning that ferric citrate has the potential to cause iron overload. This warning caused Keryx’s stock price to fall by 7% immediately after the announcement.
There are several qualifications to the FDA’s approval of ferric citrate. Keryx is not allowed to use the brand name Zerenex due to FDA concerns that it could be confused with another treatment. The company is currently working on coming up with another brand name.
Ferric citrate will compete against several therapeutics, including Sanofi’s phosphate binder Renvela (sevelamer carbonate), generic PhosLo (calcium acetate), and Velphoro (sucroferric oxyhydroxide) from Vitor Fresinius Medical Care Renal Pharma.
- Pharma Times FDA approves Keryx chronic kidney disease drug