The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food & Drug Administration recommended that Rockwell Medical Inc.'s Phase 3 Triferic efficacy and safety results support a positive benefit/risk to treat iron loss to maintain hemoglobin in patients with hemodialysis-dependent chronic kidney disease. ODAC voted in favor of Triferic by a vote of 8 to 3.Triferic is an iron-replacement drug for treating iron loss in chronic kidney disease patients receiving hemodialysis
"We welcome the committee's recommendation supporting a positive benefit/risk of Triferic," stated Robert L. 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."
ODAC reviewed safety and efficacy data from Rockwell's overall clinical program. During the clinical program more than 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given.