FDA investigating risk of Prolia for patients on dialysis

The US Food and Drug Administration (FDA) today revealed it is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).

Prolia is marketed by US biotech major Amgen (Nasdaq: AMGN) and is its second biggest seller, generating third-quarter 2022 revenues of $862 million. The drug, at a higher dose and under thetrade name Xgeva, is also marketed as a bone cancer treatment.

The FDA said its review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or low calcium levels in the blood, in patients with advanced kidney disease. Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death.