Velphoro Approval Expanded to Pediatric Patients

The US Food and Drug Administration has expanded the approval of Velphoro (sucroferric oxyhydroxide) for use in patients as young as 9 years of age. The drug, which is used to control serum phosphorus levels in patients with chronic kidney disease (CKD) receiving dialysis, was previously approved only for adults.

Expanded approval was granted based on data from a phase 3 study involving pediatric patients with hyperphosphatemia and advanced CKD. Patients who received Velphoro versus Phoslyra (calcium acetate) had a least squares mean reduction in serum phosphorus levels of −0.52 mg/dL (95% CI, −0.97 to −0.07). At the end of the 10-week dose titration period, 64% of patients had serum phosphorus levels within the normal range compared with 39% at baseline.

The suggested starting dose is one 500-mg chewable tablet twice daily with meals for patients younger than 12 years of age and one 500-mg tablet thrice daily with meals for patients aged 12 years and older. Velphoro remains unapproved for patients younger than 9 years of age due to the lack of an appropriate dosage strength.