Feb. 13, 2013
Bayer HealthCare announced today 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.
"We are pleased the FDA has granted priority review of the radium-223 new drug application for the treatment of patients with castration-resistant prostate cancer that has metastasized to the bones. Receiving this designation marks another positive milestone for radium-223 and underscores Bayer's ongoing commitment in oncology," stated
Pamela A. Cyrus
, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.
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.
, Bayer signed an agreement with Algeta ASA (
) 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 U.S.
About Radium Ra 223 Dichloride
Radium Ra 223 dichloride (radium-223), formerly referred to as radium-223 chloride, is an investigational alpha particle-emitting pharmaceutical in development for CRPC patients with bone metastases.
Radium-223 is an investigational agent and is not approved by the FDA, the European Medicines Agency (EMA), or other health authorities. Bayer has submitted a Marketing Authorization Application to the EMA for radium-223 in
for the treatment of CRPC patients with bone metastases.
, the U.S. Nuclear Regulatory Commission (NRC) issued a licensing decision on the medical use of radium-223. The decision states that U.S. medical sites will be able to procure and administer radium-223 under 10 CFR Part 35, Subpart E, which includes 10 CFR section 35.300.