FDA approval of keryx pharmaceutical iron citrate for the control of serum phosphorus level in patients with chronic kidney disease dialysis

On September 5, keryx biopharmaceutical announced that FDA approved the use of ferric citrate for the control of serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) "It's a drug that demonstrates clear profitability for a very sick, heavy-duty patient population," CEO bentsur commented, adding that the company will launch the drug within the next 12 months FDA's decision was based on data from later clinical trials, which showed that iron citrate reduced serum phosphorus levels to within the KDOQI guideline range of 3.5mg/dl to 5.5mg/dl In particular, research data released last year showed that the drug significantly reduced serum phosphorus levels in patients with end-stage dialysis nephropathy compared with placebo King, an analyst at JPMorgan securities, commented that keryx's treatment "is easy to use and requires a small number of tablets per meal." Analysts also pointed out that the ability of iron citrate to increase iron storage will give the drug an advantage over similar therapeutic drugs, such as Sanofi's sviram carbonate and Fresenius's calcium acetate Keryx has previously said that this will allow patients to reduce the use of anemia drugs However, the FDA approved iron citrate label warns that the drug can cause "iron overload," and doctors must monitor patients' iron levels during treatment "In dollar terms, the overall U.S phosphorus bond market is about $1.2 billion and has been growing year by year," bentsur commented "We believe that in the next few years, iron citrate has the potential to become a leading product in this market." He added Although keryx did not disclose the cost of the drug, analysts said the annual cost of the drug would be set at $5000 to $7500 At the same time, Markham group analyst Kolbert believes that iron citrate will face competition from carbonation svirum, which controls about half of the CKD market Kolbert predicted that iron citrate will occupy 8% of the market share next year "The expiration of the carbonation sviram patent in September has prompted people to worry about low-cost generic drugs competing with iron citrate," Kolbert said The FDA recently cancelled approval of the iron citrate brand name zerenex, noting that the name is similar to another product on the market Keryx pointed out that a new brand name would be chosen before the drug was launched The company has the right to ferric citrate in Europe, North America and Japan It has submitted the listing application of the drug to Europe as a treatment for hyperphosphatemia in patients with chronic kidney disease (including dialysis and non dialysis dependent patients) Iron citrate is also being developed in the United States as a treatment drug for iron deficiency anemia in 3-5 stage non dialysis dependent CKD patients A key phase 3 trial is expected to start soon Source address: http:// TSID = 28? Ion? Id = 2? Axzz3cu5ni7ce