EMA unit backs approval of Bayer's radium-233

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended German drug major Bayer’s (BAYN: DE) radium Ra 223 dichloride (radium-223) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

The decision of the European Commission on the approval is expected in the fourth quarter of 2013. Radium-223 was approved by the US Food and Drug Administration earlier this year under the brand name Xofigo (The Pharma Letter May 16). The drug is licensed from Norway’s Algeta (OSE: ALGETA), which co-promotes Xofigo in the USA.

The CHMP recommendation is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.