The ferric derisomaltose injection received FDA approval for the treatment of iron-deficiency anemia in adults who are intolerant to oral iron, whose disease has not responded to oral iron, or who have non-hemodialysis-dependent chronic kidney disease.
The agency granted approval based on safety and efficacy results from two randomized, open-label clinical trials of ferric derisomaltose in a total of 3,050 patients with iron-deficiency anemia of different etiologies. In the first trial, (FERWON-IDA), participants were randomized 2:1 to receive ferric derisomaltose or iron sucrose. The trial results demonstrated non-inferiority between the two therapies, with patients in both arms demonstrating a mean change in hemoglobin of 2.49 g/dL from baseline to week 8.
In FERWON-NEPHRO, which included patients with iron-deficiency anemia who had non–dialysis-dependent chronic kidney disease, patients were again randomized to the same treatment arms. Again, ferric derisomaltose was non-inferior to iron sucrose, with a mean hemoglobin increase from baseline to week 8 of 1.22 g/dL (compared with 1.14 g/dL in the iron sucrose group).
In both trials, the most common AEs reported with ferric derisomaltose included nausea (1.2%) and rash (1.0%).
Ferric derisomaltose injection has been approved in several countries outside of the U.S., including Canada and Australia, as well as in the European Union.
Source: Pharmacosmos Therapeutics press release, January 29, 2020.