FDA News

FDA approves Monoferric injection for iron deficiency anemia

The FDA approved ferric derisomaltose injection for the treatment of iron deficiency anemia in adults who had an intolerance or unsatisfactory response to oral iron or who have nonhemodialysis-dependent chronic kidney disease, according to a press release from the drug’s manufacturer.

The FDA based its approval of ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc.) — an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose — on data from two randomized, open-label clinical trials.

In the FERWON-IDA trial, researchers randomly assigned 1,512 adults with iron deficiency anemia — who had intolerance to or an unsatisfactory response to oral iron or for whom a clinical need existed for rapid repletion of iron stores — 2:1 to a 1,000 mg ferric derisomaltose injection or iron sucrose. Patients in both study groups experienced a mean change in hemoglobin of 2.49 g/dL from baseline to week 8, demonstrating noninferiority of ferric derisomaltose.

The FERWON-NEPHRO trial included 1,538 patients with nonhemodialysis-dependent chronic kidney disease who also were randomly assigned to 2:1 to ferric derisomaltose or iron sucrose. Mean increase in hemoglobin from baseline to week 8 was 1.22 g/dL in the ferric derisomaltose group compared with 1.14 g/dL in the iron sucrose group, again establishing noninferiority.

In total, 8.6% of patients who received ferric derisomaltose in both trials experienced an adverse event, the most common of which were nausea (1.2%) and rash (1%). Six patients (0.3%) experienced serious or severe hypersensitivity reactions to the injection.

“Iron deficiency anemia remains a serious health issue both in the United States and globally,” Michael Auerbach, MD, FACP, clinical professor of medicine at Georgetown University School of Medicine, said in the release. “I am very happy that Monoferric, which is supported by a robust clinical trial program, is now approved in the United States for administration of a total dose infusion in a single visit, making it the first IV iron formulation in the United States to receive such an approval.”

The FDA approved ferric derisomaltose injection for the treatment of iron deficiency anemia in adults who had an intolerance or unsatisfactory response to oral iron or who have nonhemodialysis-dependent chronic kidney disease, according to a press release from the drug’s manufacturer.

The FDA based its approval of ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc.) — an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose — on data from two randomized, open-label clinical trials.

In the FERWON-IDA trial, researchers randomly assigned 1,512 adults with iron deficiency anemia — who had intolerance to or an unsatisfactory response to oral iron or for whom a clinical need existed for rapid repletion of iron stores — 2:1 to a 1,000 mg ferric derisomaltose injection or iron sucrose. Patients in both study groups experienced a mean change in hemoglobin of 2.49 g/dL from baseline to week 8, demonstrating noninferiority of ferric derisomaltose.

The FERWON-NEPHRO trial included 1,538 patients with nonhemodialysis-dependent chronic kidney disease who also were randomly assigned to 2:1 to ferric derisomaltose or iron sucrose. Mean increase in hemoglobin from baseline to week 8 was 1.22 g/dL in the ferric derisomaltose group compared with 1.14 g/dL in the iron sucrose group, again establishing noninferiority.

In total, 8.6% of patients who received ferric derisomaltose in both trials experienced an adverse event, the most common of which were nausea (1.2%) and rash (1%). Six patients (0.3%) experienced serious or severe hypersensitivity reactions to the injection.

“Iron deficiency anemia remains a serious health issue both in the United States and globally,” Michael Auerbach, MD, FACP, clinical professor of medicine at Georgetown University School of Medicine, said in the release. “I am very happy that Monoferric, which is supported by a robust clinical trial program, is now approved in the United States for administration of a total dose infusion in a single visit, making it the first IV iron formulation in the United States to receive such an approval.”