Velphoro (sucroferric oxyhydroxide / PA21) is an iron-based Ca-free phosphate binder for treating Hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
The drug was developed by Vifor Pharma and Fresenius Medical Care, and received US Food and Drug Administration (FDA) approval in November 2013 for the control of serum phosphorus levels in CKD patients on dialysis.
Velphoro is also being reviewed by the regulatory authorities in Europe, Switzerland and Singapore for the marketing authorisation. The decision on the marketing approvals is anticipated by the first half 2014.
The drug is recommended to be administered with starting dose of three tablets per day, one tablet per meal.
Hyperphosphatemia involves the abnormal increase in the blood phosphorus levels in CKD patients undergoing dialysis.
The recommended phosphorus levels in accordance with KDOQI guideline are between 1.13mmol/L and 1.78mmol/L, and controlling serum phosphate is important in these patients.
It is estimated that, depending on the region, around 50% of the CKD patients on dialysis are unable to obtain or maintain the target serum phosphorus levels due to the high pill burden and poor tolerability of current phosphate binders in the market.
On average, dialysis patients take 19 pills in a day with phosphate binders comprising approximately 50% of the total daily pill burden.
How Velphoro works
Velphoro is a chewable, iron-based phosphate binder containing a mixture of polynuclear iron (III)-oxyhydroxide, sucrose and starches. When taken with meals, Velphoro adsorbs the dietary phosphate in the gastrointestinal tract and prevents its uptake into the blood. The adsorbed phosphate is subsequently eliminated through the faeces.
Velphoro clinical trials
The Velphoro clinical programme clearly demonstrated efficacy in serum phosphorus control and tolerability. The Phase II clinical trial met both its primary and secondary endpoints. The serum phosphorus lowering efficacy doses of 1.0g/day and 1.5g/day was numerically comparable to 4.8g/day sevelamer hydrochloride. Velphoro was also well-tolerated, with a comparable overall safety and tolerability profile.
Its Phase III clinical trial was an open-label, randomised, active controlled, parallel group study. It enrolled more than 1,000 patients. It investigated the efficacy and safety of Velphoro in comparison with sevelamer carbonate, the current standard of care in CKD patients on dialysis, and efficacy of the maintenance dose compared to the low dose (250 mg/day) of Velphoro.
The phase III study also met both primary (superiority of maintenance dose of Velphoro vs low, ineffective, dose) and secondary endpoints (non-inferiority of Velphoro vs sevelamer carbonate) and showed that Velphoro controls hyperphosphatemia with fewer pills (3.3 pills /day) when compared to sevelamer carbonate (8.7 pills/day). Phase III studies also proved that Velphoro has effective tolerability.
Manufacturing and marketing of Velphoro
Vifor Pharma, the pharma business sector of the Galenica Group, is one of the world’s leaders in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency.
The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.
Velphoro is manufactured by Vifor Pharma in Switzerland. In 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma, a common company established by Galenica and Fresenius Medical Care.
Fresenius Medical Care North America will now launch Velphoro in the US market. Velphoro is regarded as a great option for dialysis patients to control phosphate with 1 pill/meal which might support their adherence and offers a sustained therapeutic effect.
Kissei Pharmaceuticals holds the co-development rights of Velphoro in Japan.