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Injectafer (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency in adult patients with iron deficiency in adult patients with heart failure categorized.
Evrenzo (roxadustat) was non-inferior to ESA for risk of a major adverse cardiovascular event, and major adverse cardiovascular event plus congestive heart failure or unstable angina requiring hospitalization with a consistent finding for all-cause mortality.
Roxadustat increases hemoglobin (Hb) levels through a different mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs) which are typically co-administered with intravenous iron.
The results of this program support roxadustat as efficacious in achieving and maintaining target Hb levels (10-12g/dL) in patients with symptomatic anemia of CKD regardless of dialysis status and irrespective of prior ESA treatment.
As a HIF-PH inhibitor, roxadustat activates the body's natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia with a reduced need for intravenous iron.
The U.S FDA has approved a single 1000 mg dose option of Injectafer®, ferric carboxymaltose injection, an iron replacement product, for iron deficiency anemia patients who have intolerance to oral iron, have low response to oral iron, or have non-dialysis dependent CKD.
The MHLW approval of EVRENZO marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.
Under the terms of the agreement, upon close, Corza Health will acquire the assets and licenses that support the development and commercialization of TachoSil®, while Takeda will maintain ownership of the manufacturing facility in Linz, Austria.