CAMBRIDGE, Mass.--(BUSINESS WIRE)--PROMETRIKA, LLC extends its congratulations to our colleagues at Progenics Pharmaceuticals, Inc., on the recent approval of Azedra® (iobenguane I 131). PROMETRIKA is honored and proud to have supported Progenics through the integrated safety and efficacy analyses and preparation of the NDA submission documents for the approval of Azedra. The new treatment is approved for the treatment of adult and pediatric patients 12 years and older with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. Azedra is the first treatment approved in the US for these ultra-rare tumors. The FDA’s announcement of this milestone approval can be found at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615155.htm.
About PROMETRIKA, LLC - www.prometrika.com
Founded
in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a unique
Clinical Research Organization, utilizing a collaborative approach to
clinical development and execution with a close-knit, highly-experienced
senior leadership team that remains involved throughout the duration of
each trial. PROMETRIKA’s services include complete clinical operations
and clinical trial management, data management, pharmacovigilance,
biostatistics and programming, medical writing, and regulatory
submissions.
About Progenics Pharmaceuticals - www.progenics.com
Progenics develops innovative medicines and other technologies to target and treat cancer, including: (1) therapeutic agents designed to treat cancer (AZEDRA®, 1095, and PSMA TTC); (2) prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (1404 and PyLTM); and (3) imaging analysis technology. Progenics has two commercial products, RELISTOR® (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation, which is partnered with Salix Pharmaceuticals, Inc. (a wholly-owned subsidiary of Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals International, Inc.)); and AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy.
