恩瑞格可治疗什么病症呢？

Convenience is better and patient compliance is higher. EPIC is currently the largest prospective, open, single-group, global multi-center clinical study designed for patients with iron overload. A total of 341 MDS patients were enrolled, and it could reduce serum ferritin by an average of 372 μg/L in 3 months. Today let’s take a look at what diseases Enrig can treat?

On January 23, the U.S. Food and Drug Administration (FDA) approved a new indication for Enriga (defesirol) for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT). NTDT is a mild form of thalassemia that does not require frequent blood transfusions. But over time, NTDT patients are at risk for iron overload, which can lead to fatal organ damage. The FDA also approved the marketing of FerriScan as an imaging companion diagnostic reagent from Enrig. The FDA has previously approved FerriScan for the detection of liver iron concentration (LIC), but its use in Enrig clinical studies is to screen patients for clinical treatment and manage treatment. Its use is limited to imaging and diagnostic reagents necessary for the safe and effective application of Enrig.

Enrig was previously approved for the treatment of iron overload due to transfusion in patients 2 years of age and older, and this approval allows Enrig to be used in patients with NTDT iron overload. Enrig should be used in patients with NTDT who have at least 5 mg of iron per 1 g of desiccated liver tissue. Enrig's new indication was approved by the FDA through the accelerated approval process, which allows patients to have early access to this promising new drug to treat serious or life-threatening diseases, while the company conducts additional studies to ensure Enrig's clinical effectiveness.

In summary, Enrego is an iron chelator indicated for the treatment of chronic transfusion-induced iron overload in patients 2 years of age and older. This indication was approved under accelerated approval based on reductions in hepatic iron concentrations and serum ferritin levels. Continued approval for this indication may be contingent upon verification and characterization of clinical benefit in confirmatory trials.

Enrig is indicated for the treatment of chronic iron overload dry weight (Fe/gdw) and serum ferritin greater than 300 mcg/L in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndrome and a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram dry weight (Fe/gdw). This indication was approved under accelerated approval based on reductions in liver iron concentration (less than 5 mg Fe/gdw) and serum ferritin levels.

The above is the content of the indications, I hope it can help you!