Authors: Jade Parker, Editor
It was recently announced by Astellas Pharma Inc. (Tokyo, Japan) that gilteritinib has received Orphan Designation for acute myeloid leukemia (AML) from the European Commission. The announcement follows the recent Orphan Drug Designation in the United States granted by the FDA to gilteritinib in mid-2017.
We spoke with, Steven Benner, Senior Vice President and Global Therapeutic Area Head of Oncology Development at Astellas to find out more about the designation:
Why has gilteritinib been granted an orphan designation?
An Orphan Designation is granted to a medicine that has the potential to benefit patients with a rare disease. Astellas received an Orphan Designation from the European Commission for gilteritinib for the treatment of AML. To receive an Orphan Designation in the European Union, a medicine must meet a number of criteria.