Finally, Keryx Biopharmaceuticals Inc has received green signal from the FDA for its drug, ferric citrate, to reduce phosphate levels in patients living with chronic kidney disease (CKD).

The approval has not come easy as the company would be required to put safety warning on the label. The label will have the information that patients who are given additional iron dosage intravenously might require to reduce the dosage or all-together stop having additional iron therapy. It has been said so as the treatment has shown to increase iron levels.

For now, ferric citrate is the only drug in its class that increases the iron content in the body. But the FDA label does not include benefits of the drug in improving anemia. FBR Capital Markets & CO analyst Andrew Berens does not find the label to be quite an effective one, as it does not highlight about anemia.

In CKD, kidneys do not function properly and fail to flush out waste. Due to this inability, phosphate level increases in the blood and is marked by a condition called hyperphosphatemia. The condition can also lead to acute iron deficiency.

Keryx stated that working of ferric citrate is very simple, but quite effective. The drug attaches to any phosphate ingested with food ensuring that it is not absorbed by the body. It also increases the blood iron levels.

The drug will be introduced in the market in next 12 months. "In terms of dollars, the total U.S. market size for phosphate binders is about $1.2 billion, which has been growing on a year-over-year basis", stated Keryx CEO Ron Bentsur.

Bentsur is hoping to see ferric citrate to be a leading product in the market. The drug will face competition from French drug-maker Sanofi SA's Renvela. Currently, it is dominating half the market for CKD, shared Maxim Group Analyst Jason Kolbert.

The drug is expected to be priced between $5,000 and $7,500 a year. Experts are expecting that by 2015, the drug will capture around 8% of the market.