Sucroferric Oxyhydroxide (1) – Velphoro®

• Clinical trials
  • To assess the additional benefit of sucrroferric oxyhydroxide compared with the appropriate comparator therapy (sevelamer), the pharmaceutical manufacturer presents the two open-label, randomised, controlled, multicentre trials PA-CL-03A and PA-CL-05A/05B.
  • The 6-arm Phase II trial PA-CL-03A investigated adult patients with chronic renal failure undergoing haemodialysis and with a serum phosphate level of at least 1.78 mmol/l. Sucroferric oxyhydroxide, administered in five fixed doses, was compared with sevelamer hydrochloride at a fixed dose of 4.8 g/day.
  • The PA-CL-05A/05B study is an open-label, randomised, controlled, multicentre Phase III study. Sucroferric oxyhydroxide was compared with sevelamer carbonate.

Adults with chronic renal failure undergoing haemodialysis or peritoneal dialysis for the control of serum phosphate levels

• No additional benefit of Sucroferric Oxyhydroxide for treatment compared with the appropriate comparator therapy (sevelamer) is not proven.
• The pharmaceutical manufacturer does not present separate results for patients who are eligible for treatment with calcium-containing phosphate binders. The dossier presents results only for the entire study populations of studies PA-CL-03A and PA-CL-05A/05B, as well as for the patient population with a contraindication to calcium-containing phosphate binders (see b)). The pharmaceutical manufacturer has not submitted any suitable studies for the assessment of additional benefit, neither separately for this patient population nor for the overall population (see comments on pages 5–9). An additional benefit compared with the appropriate comparator therapy is therefore not proven for patients for whom treatment with calcium-containing phosphate binders is suitable.

Adults with chronic renal failure undergoing haemodialysis or peritoneal dialysis to control serum phosphate levels, for whom calcium-containing phosphate binders are contraindicated according to the SmPC (e.g. hypercalcaemia)

• An additional benefit of sucroferric oxyhydroxide over the appropriate comparator therapy, sevelamer, is not proven.
• To assess the additional benefit of Sucroferric Oxyhydroxide compared with the appropriate comparator therapy (Sevelamer) in patients for whom calcium-containing phosphate binders are contraindicated according to the SmPC, the pharmaceutical manufacturer presents results from the patient populations of the two studies PA-CL-03A and PA-CL-05A/05B, which comprise patients with a contraindication to calcium-containing phosphate binders. However, as the two studies submitted by the pharmaceutical manufacturer in the dossier are, for the reasons set out above, (pages 5–9), the additional benefit of Sucroferric Oxyhydroxide in this patient population is not proven.

Courtesy translation only, please refer to the German original.