On August 31, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other products for targeting and treating cancer, reported that it has been notified by its third-party vendor that the commercial drug product manufacturing facility for AZEDRA requires more time to prepare for pre-approval inspection by the U.S. Food and Drug Administration (FDA) (Press release, Progenics Pharmaceuticals, AUG 31, 2017, View Source [SID1234520348]). As a result, after consultation with the FDA, Progenics has decided to postpone the finalization of the New Drug Application (NDA) until the manufacturing site is inspection-ready. The manufacturer has indicated it will need up to a few months to complete this work. Under a rolling submission, Progenics has submitted all portions of the NDA to the FDA, except for the notification of pre-approval inspection readiness.
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"We are committed to filing a high-quality application for AZEDRA and I believe that postponing the completion of the submission to permit the manufacturer time to prepare for their inspection is a worthwhile investment. Our interactions with the FDA on the AZEDRA rolling submission continue to be positive and productive. We understand that this delay could be up to eight to twelve weeks, and we look forward to providing an update as our manufacturer advances through their pre-approval inspection work," said Mark Baker, Chief Executive Officer of Progenics. "This delay is unrelated to the manufacturing process for AZEDRA, which is robust and has been validated. This delay is also unrelated to the quality of the data we have generated for AZEDRA, which we believe demonstrate the potential of this much-needed therapy to deliver significant and meaningful clinical benefit to patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma."
Data from the pivotal Phase 2b study of AZEDRA, including new data for key secondary endpoints, will be presented at the 5th International Symposium on Pheochromocytoma and Paraganglioma in Sydney, Australia on September 1, 2017 at 10:30 a.m. Eastern Australia Time. The data will be highlighted during an oral presentation entitled "AZEDRA (iobenguane I 131) in Patients with Malignant and/or Recurrent and/or Unresectable Pheochromocytoma or Paraganglioma: Final Results of a Multi-Center, Open-Label, Pivotal Phase 2b Study".
About AZEDRA
AZEDRA (iobenguane I-131), a radiotherapeutic product candidate in development as a treatment for malignant and/or recurrent pheochromocytoma and paraganglioma, rare tumors found in the adrenal glands and outside of the adrenal glands, respectively. AZEDRA has been granted Breakthrough Therapy and Orphan Drug designations, as well as Fast Track status in the U.S. Under a SPA agreement with the U.S. Food and Drug Administration (FDA), a Phase 2 pivotal study has been completed in patients with malignant and/or recurrent and/or unresectable pheochromocytoma and paraganglioma. There are currently no FDA-approved therapies for the treatment of these ultra-orphan diseases.