Generic drug maker Emcure Pharmaceuticals has launched India’s first generic version of sucroferric oxyhydroxide indicated for the control of increased serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. This generic version will be sold under the brand name Dynulta. The active component (API) for the branded generic, which is manufactured at Emcure’s Jammu formulation plant, was developed indigenously by the Pune-based drug maker.
Emcure executives said that Dynulta will be marketed at less than 70% cost of the innovator brand—Velphoro, which was owned and marketed by Vifor Pharma and Fresenius Medical Care. Sucroferric oxyhydroxide was invented by Renal Pharma, a joint venture between Vifor International and Fresenius Medical Care. Velphoro was not avaible in the India.
“Since the incidence of CKD is on the rise in India, Dynulta, the low cost generic, will provide efficacious and cost-effective remedy for Indian patients” said Namita Thapar, Executive Director, Emcure Pharmaceuticals.
Recent data from the International Society of Nephrology’s Kidney Disease Data Centre reported a prevalence of 17% of CKD in India. Diabetes and hypertension accounts for most CKD cases. By 2030, India is expected to have the world’s largest population of diabetes patients. There are several other issues that contribute to the high prevalence of CKD in India.
Hyperphosphatemia is a serious and common consequence of advanced CKD. Hyperphosphatemia is associated with increased risk of cardiovascular events and mortality in patients undergoing dialysis. Dietary restrictions and dialysis alone are usually insufficient to control hyperphosphatemia therefore an effective phosphate binder is needed to control increased phosphate level.
Sucroferric oxyhydroxide displays a high phosphate binding capacity, resulting in effective serum phosphorous control. This was demonstrated in a phase III study of sucroferric oxyhydroxide versus sevelamer. Real-world studies show that patients who switch to sucroferric oxyhydroxide from another phosphate binder achieve better long-term serum phosphorous control with a lower number of pills. A lower pill burden can translate into better patient compliance to treatment. Studies have shown that sucroferric oxyhydroxide is effective in the reduction of serum phosphorous in a broad range of dialysis patients.