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US FDA accepts Progenics Pharma's NDA for Azedra to treat rare neuroendocrine tumours

New York
Wednesday, January 3, 2018, 13:00 Hrs  [IST]

Progenics pharmaceuticals, an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, announced that the us food and drug administration (fda) has accepted for review the new drug application (NDA) for Azedra in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumours. The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA).

“With no FDA-approved therapies for these rare tumours, Azedra has the potential to address the high unmet need of patients with malignant pheochromocytoma and paraganglioma,” said Mark Baker, chief executive officer of Progenics. “We are pleased that the FDA has accepted our NDA with Priority Review, and look forward to working with the Agency during the review process. At the same time, we will continue to lay the groundwork for our commercial plan and prepare to launch quickly following a potential approval.”

The NDA is supported by data from a pivotal phase 2b open-label, multi-center trial that was conducted under a Special Protocol Assessment (SPA) with the FDA. The trial met the primary endpoint evaluating the proportion of pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medication for at least six months, and showed favorable results from a key secondary endpoint evaluating the proportion of patients with overall tumour response as measured by Response Evaluation Criteria In Solid Tumors (RECIST). Azedra was also shown to be safe and generally well tolerated.

Azedra (iobenguane I 131) is a high-specific-activity radiotherapeutic product candidate in development as a treatment for malignant, recurrent, or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumours of neural crest origin. Azedra is a substrate for norepinephrine reuptake transporter which is highly expressed on the cell surface of neuroendocrine tumours. Azedra has been granted Orphan Drug designation, Fast Track status, and Breakthrough Therapy designation in the US. Under a SPA agreement with the FDA, a phase 2b pivotal study has been completed in patients with malignant, recurrent, or unresectable pheochromocytoma and paraganglioma. There are currently no FDA-approved therapies for the treatment of this ultra-rare disease.


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