The FDA shot down Keryx Biopharmaceuticals’ request for five-year new chemical entity (NCE) exclusivity for its Auryxia (ferric citrate) oral tablets, but it approved the drugmaker’s petition for three-year exclusivity.
The drug manufacturer claimed that it had earned three years of exclusivity based on a 2017 indication that was approved for the treatment of iron deficiency anemia in patients with non-dialysis-dependent chronic kidney disease (CKD). It based its claims on a clinical investigation it conducted, a 24-week placebo-controlled phase III trial in 234 adults with stage three to five non-dialysis-dependent CKD.
The FDA agreed, basing its approval on the company’s clinical investigations. It subsequently updated the Orange Book to include the drug’s new exclusivity.