US FDA grants priority review for radium-223

The U.S. Food and Drug Administration (FDA) has granted a priority review for radium-223 dichloride in the treatment of men with castration-resistant prostate cancer (CRPC) and bone metastases.

A media release issued earlier today by Bayer HealthCare states that the New Drug Application (NDA) for radium-223 has been accepted for filing by the FDA as well as being given this priority review. The priority review implies that the FDA will make a decision about the approvability of the NDA by something like August this year (or earlier).

Bayer HealthCare and Algeta will co-promote radium-223 in the USA if the FDA grants an approval for radium-223 in the management of CRPC in association with bone metastasis. The product is already available to eligible patients through an expanded access initiative, as previously reported.

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