Posted by Michael Wonder on 05 Nov 2017
Progenics Pharmaceuticals completes submission of NDA for Azedra (iobenguane I 131) in pheochromocytoma and paraganglioma
2 November 2017 - Progenics Pharmaceuticals announced today that it has completed the rolling submission of its new drug application for Azedra in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumours.
Azedra has received breakthrough therapy, orphan drug and fast track designations from the FDA. There are currently no approved therapeutics in the U.S. for the treatment of malignant, recurrent, and/or unresectable pheochromocytoma or paraganglioma.
The application remains subject to FDA regulatory review and approval.
