Deferasirox上市的时间

It is an oral iron chelator approved by the FDA for the treatment of chronic iron overload caused by blood transfusion. Deferasirox is from Novartis. Later, the FDA approved the expanded indication of Deferasirox to treat chronic iron excess caused by non-transfusion-dependent thalassemia, making Deferasirox the first drug to treat this indication.

So, when will Deferasirox be launched?

Availability of Deferasirox:

In November 2005, Deferasirox was approved by the FDA for use in patients 2 years of age and older with chronic iron overload caused by blood transfusions.

In 2010, Deferasirox was approved for marketing in China and is approved for the treatment of chronic iron overload caused by frequent blood transfusions in beta-thalassemia patients aged 2 years and above and chronic iron overload in patients with non-transfusion-dependent thalassemia (NTDT) syndrome aged 10 years and above. 

In December 2012, Deferasirox was approved by the European Commission for the treatment of chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndrome who require chelation therapy due to contraindications or insufficiency of deferoxamine mesylate therapy.

On January 23, 2013, the FDA approved a new indication for Deferasirox for the treatment of chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT). 

Studies have shown that after chelation therapy, 42.7% of patients achieved a hematological response and reduced the need for blood transfusions. There may be a dynamic, bidirectional regulatory mechanism between erythropoiesis and iron overload. On the one hand, ineffective erythropoiesis can lead to increased intestinal iron absorption through reduced hepcidin secretion by the liver. On the other hand, chelation treatment of iron overload can improve erythropoiesis, increase hemoglobin levels, and reduce clinical blood transfusions.