The panel voted eight to three on Thursday night in favor of recommending the therapy's approval after determining that the benefits of Triferic outweighed the risks for maintaining iron stores and hemoglobin in patients on kidney dialysis.
The panel reviewed safety and efficacy data from Rockwell's clinical program that treated more than 1,400 patients with Triferic through more than 100,000 individual administrations.
"We welcome the committee's recommendation supporting a positive benefit/risk of Triferic," said Robert L. Chioini, founder, chairman and CEO of Rockwell, in a statement. "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."
For more on this story, read TheStreet's Adam Feuerstein's in-depth coverage here.RMTI data by YCharts