Fresenius’ North America unit this year will launch a drug approved in late November by the U.S. Food and Drug Administration.
Velphoro (sucroferric oxyhydroxide) received approval for controlling serum phosphorus levels in dialysis patients with chronic kidney disease.
The new drug, known previously in trials as compound PA21, is a chewable form of a phosphate binder that is iron based and free of calcium. A phase 3 study showed that Velphoro successfully controlled hyperphosphatemia with fewer pills than sevelamer carbonate (Renvela, Sanofi), which is currently used by many patients on dialysis.
Individuals on dialysis swallow on average 19 pills per day; about half of these are phosphate binder pills. By contrast, the average daily dose to control hyperphosphatemia was 3.3 Velphoro pills per day after 52 weeks. The recommended starting dose for the new medication is one tablet per meal, three times daily.
Vifor Fresenius Medical Care Renal Pharma’s chief executive Charles DeLoach said his company aimed to achieve the right balance between the pills having enough pliability to keep the tablets in one piece yet soft enough to be chewed easily. Many dialysis patients have difficulty chewing tablets.
The company reported that regulatory reviews in Europe and Singapore for drug approval were expected in the first half of 2014.
