EMA's PRAC recommends restrictions on Xofigo; elects new chair

13 July 2018

Following a review of data showing a possible risk of earlier death and an increase in fractures with Xofigo (radium-223 dichloride), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of this cancer medicine to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments.

Xofigo is a drug marketed by Germany’s Bayer (BAYN: DE)

The PRAC also confirmed its previous interim recommendation that the medicine must not be used with Zytiga (abiraterone acetate) and prednisone/prednisolone. Zytiga is marketed by US healthcare giant Johnson & Johnson (NYSE: JNJ).

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