Bayer HealthCare announced today that the the European Committee for Medicinal Products for Human Use (CHMP) recommended Xofigo® (radium Ra 223 dichloride) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. The decision of the European Commission on the approval is expected in the second half of 2013. Xofigo was approved by the U.S. Food and Drug Administration in May for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the United States at licensed facilities.
"We are encouraged by the positive CHMP opinion issued today, and look forward to potentially providing radium 223 to more patients upon approval of the European Commission," explained Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
Bayer HealthCare Pharmaceuticals Inc.