Pharmacosmos Therapeutics Inc. announced the FDA granted approval of ferric derisomaltose injection for the treatment of iron deficiency anemia.
A new single-dose injection therapy for the treatment of iron deficiency in adults has received approval from the US Food and Drug Administration (FDA), according to a press release from Pharmacosmos Therapeutics Inc.
Pharmacosmos Therapeutics announced on Wednesday morning the FDA granted approval to the ferric derisomaltose (Monoferric®) 100 mg/mL for the treatment of iron deficiency anemia (IDA) in adults patients who have an intolerance or had unsatisfactory response to oral iron or patients who have non-hemodialysis dependent chronic kidney disease (NDD-CKD).
"We are very pleased with the FDA's approval of (ferric derisomaltose) as the first intravenous iron product approved in the United States for the infusion of 1000 mg as a single dose in one visit for patients with iron deficiency anemia," said Michael Ryde, CEO of Pharmacosmos Therapeutics, in a press release. "We are excited to provide this new innovative treatment to US physicians."
The approval ferric derisomaltose 100 mg/mL injections is supported by data from 2 randomized, open-label trials in more than 3000 patients with IDA. Results of the 8-week trials demonstrated the noninferiority of ferric derisomaltose for change in hemoglobin from baseline to compared to iron sucrose.
Prescribing information for ferric derisomaltose recommends a dose of 1000 mg by intravenous infusion over at least 20 minutes as a single dose for patients weighing 50 kg or more—with clinicians repeating dose if iron deficiency anemia reoccurs. In patients weighing under 50 kg, the recommended dose is 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose—with clinicians repeat dose if iron deficiency anemia reoccurs.
The prescribing information notes the dosage is expressed in mg of elemental iron and each mL of ferric derisomaltose contains 100 mg of elemental iron.
Ferric derisomaltose injection is contraindicated in patients with a history of serious hypersensitivity to ferric derisomaltose or any of its components. Prescribing information recommends monitoring patients for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable following completion of infusion. The most commonly reported adverse reactions—defined as an incidence of 1% or greater—with ferric derisomaltose injections were rash(1.0%) and nausea(1.2%).
"I am very happy that (ferric derisomaltose), which is supported by a robust clinical trial programme, is now approved in the United States for administration of a total dose infusion in a single visit, making it the first intravenous iron formulation in the United States to receive such an approval," said Michael Auerbach, MD, clinical professor of Medicine at Georgetown University School of Medicine, in the release from Pharmacosmos Therapeutics.
Pharmacosmos Therapeutics noted in their release that ferric derisomaltose is also known as iron isomaltoside 1000—the generic name initially approved in the European Union and other markets. Ferric derisomaltose was initially approved in the European Union in 2009 as iron isomaltoside 1000 injection (Monofer).