Rockwell Medical Surges As FDA Panel Recommends Triferic In Hemodialysis Patients
November 7, 2014
By Riley McDermid, BioSpace.com Breaking News Staff
Rockwell Medical, Inc . saw its share price soar more than 18 percent in morning trading Friday after a panel at the U.S. Food and Drug Administration recommended that a recent Phase III study on the firm’s drug Triferic showed it was effective at treating iron loss in patients with kidney disease.
The Oncologic Drugs Advisory Committee voted 8 to 3 in favor of Triferic, saying the data presented showed a positive benefit/risk to treat iron loss to maintain hemoglobin in patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD).
Wall Street traders liked those results and stayed bullish on the stock all morning, pushing it into higher territory on the strength of the news.
Rockwell, too, lauded the stamp of approval, which is typically followed by full agency approval, as an exciting development.
"We welcome the committee's recommendation supporting a positive benefit/risk of Triferic," stated Robert Chioini, founder, chairman and chief executive officer of Rockwell. "We look forward to working with the FDA to complete its review of Triferic. We remain committed to addressing the unmet needs in managing patients with chronic kidney disease."
The panel parsed data from clinical program where more than 1,400 patients were treated with Triferic with 100,000 individual administrations of the drug. Triferic is an iron compound works by replacing the 5 to 7 mg of iron lost during each dialysis treatment. It is delivered via dialysate, after being mixed into the sodium bicarbonate concentrate given to patients where they are receiving dialysis. It then enters the blood stream, where it binds to apo-transferrin and is taken to the bone marrow, a process similar to how dietary iron is processed in the human body.
The company said that in completed clinical trials to date, “Triferic has demonstrated that it may safely and effectively” deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while “significantly reducing” ESA dose.