FDA approves Rockwell Medical's iron replacement drug

The Food and Drug Administration approved Rockwell Medical Inc's drug for treating iron loss in chronic kidney disease patients on dialysis, sending the company's shares up about 15 percent in premarket trading.

The drug, Triferic, replaces the 5-7 mg of iron patients tend to lose during each dialysis session.

Anemia is common in kidney disease patients, who lose iron either due to dialysis or because they are unable to produce erythropoietin, a hormone that helps in red blood cell production.

Triferic, which is added to the dialysis solution, is the first drug that allows dialysis patients to maintain target hemoglobin without the need for intravenous iron.

The drug delivers iron directly to the bone marrow, just like dietary iron, Stifel Nicolaus analyst Annabel Samimy said.

Iron administered intravenously is less efficient as it is encased in a shell, which goes into the liver before being delivered and gets blocked by the immune system, she said.

Samimy said she expected Triferic to hit peak sales of $200 million-$250 million in the United States.

Rockwell estimates the market for the drug at $300 million-600 million in the United States. The company pegs the global market for Triferic at more than $1 billion, with annual growth of 6-8 percent. (bit.ly/1yV4GtH)

"(The) approval is important for the company as it will take them into a higher margin drug business ..." Samimy said.

Amag Pharmaceuticals Inc's Feraheme, which was approved in 2009 for the same indication, is administered as an undiluted injection.

Keryx Biopharmaceuticals Inc is also testing its drug, Auryxia, in a late-stage trial to treat iron deficiency in non-dialysis chronic kidney disease patients.

An advisory panel to the FDA had recommended an approval for Rockwell's drug in November.