Nintedanib receives orphan drug award for mesothelioma

Release Date: 31-Jan-2017

The US Food and Drug Administration (FDA) have awarded orphan drug designation to Nintedanib for the treatment of patients with asbestos-related cancer mesothelioma.


The Nintedanib inhibits 3 categories of protein receptors that are crucial to blood-vessel production, but also play roles in tumor growth and cancer spreading to other parts of the body. These receptors are vascular endothelial growth factor receptors 1-3 (VERGFR 1-3), platelet-derived growth factor receptors (PDGFR), and fibroblast growth factor receptors 1-3 (FGFR 1-3).


Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.  The OOPD provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers.


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