The US Food and Drug Administration has given the green light to Vifor Fresenius Medical Care Renal Pharma's hyperphosphatemia drug Velphoro.
The approval for Velphoro (sucroferric oxyhydroxide), formerly known as PA21, is based on Phase III data demonstrated that the drug successfully controls the accumulation of phosphorus in the blood with the advantage of a much lower pill burden than the current standard of care in patients with chronic kidney disease on dialysis, namely Sanofi's Renvela (sevelamer carbonate).
On average, dialysis patients take 19 pills per day with phosphate binders making up about 50% of that. The recommended starting dose of Velphoro is three tablets per day (i.e. one per meal) so compliance should improve considerably.
UPDATE: Vifor Fresenius Medical Care Renal Pharma chief executive Charles DeLoach told PharmaTimes that as well as reducing the pill burden, he noted that the company asked a Swiss university to do tests so that they get the right balance between having enough pliability to keep the tablet intact yet soft enough so that it can be chewed easily, a problem for many dialysis patients.
Mr DeLoach noted that the company also did extensive taste tests in dialysis patients (many of whom suffer from altered taste buds) and of all the tastes, "by far and away" the favourite was the wildberry flavour used for Velphoro. "When you give patients something that is easy to take that tastes good, the odds of them taking the medication are much higher".
Velphoro was developed by Vifor Pharma and in 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma. It will be launched in the USA by Fresenius Medical Care North America in 2014.
Mr DeLoach told PharmaTimes that the latter has already done "a phenomenal job" in promoting the iron deficiency treatment Venofer (iron sucrose) and "we are very confident they will repeat their success with Velphoro".
The company noted that regulatory processes in Europe, Switzerland and Singapore are ongoing and decisions are expected in the first half of 2014. Further submissions are being prepared.