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ARTICLE | Company News

FDA approves radium-223 from Bayer, Algeta

May 16, 2013 12:56 AM UTC

FDA approved an NDA from Bayer AG (Xetra:BAYN) for Xofigo radium-223 dichloride to treat castration-resistant prostate cancer (CRPC) in patients with symptomatic bone metastases. Xofigo is indicated for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. The approval comes about three months before the drug's Aug. 14 Priority Review PDUFA date. Bayer said it will launch the radiopharmaceutical based on the alpha particle emitter radium-223 in one to two weeks, with a wholesale acquisition cost (WAC) of $69,000 for a course of treatment comprising six injections. ...