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FDA expedites review of Novartis drug Promacta for first-line severe aplastic anemia

Novartis said Tuesday that the US Food and Drug Administration (FDA) has accepted the its supplemental New Drug Application (sNDA) and granted Priority Review designation to Promacta (eltrombopag) in combination with standard immunosuppressive therapy (IST) for first-line treatment of severe aplastic anemia (SAA).

Promacta, which is marketed as Revolade in most countries outside the US, is an oral thrombopoietin receptor agonist (TPO-RA) that is already approved for SAA in the refractory setting for patients who have had an insufficient response to IST. It is also approved for adults and children with chronic immune thrombocytopenia (ITP) for patients who are refractory to other treatments and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus (HCV) infection.
“Promacta is a great example of our drive to develop innovative treatments in serious disease areas where few treatment options exist,” said Samit Hirawat,Head, Novartis Oncology Global Drug Development. “Thanks to the many individuals and organizations who have helped us to advance the development of this promising medicine. We will continue our work with the FDA to make Promacta available for this potential new indication as quickly as possible.”
Severe aplastic anemia is a rare, life-threatening, acquired blood disorder in which a patient’s bone marrow fails to produce enough red blood cells, white blood cells and platelets.

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