FDA updated drug safety communication on Prolia

Following its review of all available information, the US Food and Drug Administration (FDA) on Friday said it has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), particularly patients on dialysis.

Developed by US biotech major Amgen (Nasdaq: AMGN) and initially approved in 2010, denosumab is a big seller for the company, both as Prolia for the treatment of osteoporosis and Xgeva for bone cancer. The drug generated third-quarter 2023 sales of $986 million and $519 million in the respective indications.

The FDA noted that Severe hypocalcemia appears to be more common in patients with CKD who also have a condition known as mineral and bone disorder (CKD-MBD). In patients with advanced CKD taking Prolia, severe hypocalcemia resulted in serious harm, including hospitalization, life-threatening events, and death. As a result, we are revising the Prolia prescribing information to include a new Boxed Warning, FDA’s most prominent warning, communicating this increased risk.