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U.S. FDA Grants Priority Review To Bayer's Radium Ra 223 Dichloride NDA For Castration-Resistant Prostate Cancer With Bone Metastases

WAYNE, N.J., Feb. 13, 2013 /PRNewswire/ --  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. 

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 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 December 2012 for the treatment of CRPC patients with bone metastases.

In January 2013, 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.

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