Swiss firm CSL Vifor and Germany’s Fresenius Kabi have announced the first regulatory approval in China for Ferinject (ferric carboxymaltose), an iron deficiency treatment used to manage anemia in patients with chronic kidney disease and those undergoing surgery. The drug is indicated for adults with iron deficiency for whom oral iron preparations are ineffective, cannot be used, or where rapid iron delivery is clinically necessary. This approval marks the 85th global market approval for Ferinject.
Approval Context and Benefits
The approval of Ferinject is well-timed to support China’s recent introduction of patient blood management (PBM) guidelines, including perioperative PBM, which came into effect in June this year. PBM is a patient-centered, multi-disciplinary, evidence-based approach to managing blood transfusions. Pre-surgical use of Ferinject has been shown to reduce the incidence of post-surgical anemia, thereby lowering the overall cost of patient care. China has the world’s largest population suffering from iron deficiency and performs 3-4 million elective surgeries annually, according to a press release.-Fineline Info & Tech
