February 14, 2013 — Bayer HealthCare announced that the New Drug Application (NDA) for its investigational oncology compound Radium Ra 223 Dichloride (radium-223) has been accepted for filing and granted priority review by the U.S. Food and Drug Administration (FDA). The application is currently under review for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.
The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months of the 60-day filing receipt of the NDA submission (eight months total), rather than the standard 12-month review cycle.
In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide, and commercialize radium-223 globally. Algeta will co-promote radium-223 with Bayer in the United States.
For more information: www.bayer.com