Progenics Pharma (PGNX) Announces FDA Acceptance of AZEDRA NDA
Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) announced today that the U.S. 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 tumors. 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 tumors, 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 tumor response as measured by Response Evaluation Criteria In Solid Tumors (RECIST). AZEDRA was also shown to be safe and generally well tolerated.