Emcure launches India first generic version of sucroferric oxyhydroxide for chronic kidney disease patients

Emcure Pharmaceuticals has launched India’s first generic version of sucroferric oxyhydroxide for the control of increased serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The drug will be sold under the brand name Dynulta. Its active component is sucroferric oxyhydroxide developed indigenously by Emcure.

Dynulta will be manufactured at Emcure’s state-of-the-art plant at Jammu and will be marketed at less than 70 per cent cost of the innovator brand.

“The incidence of CKD is on the rise in India. Dynulta 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 per cent 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.

The innovator company for sucroferric oxyhydroxide is Vifor Fresenius Medical Care Renal Pharma Ltd, a joint operation between Vifor Pharma and Fresenius Medical care, providers of dialysis services. It is marketed internationally as Velphoro, which is not available in india. Emcure Pharmaceuticals ltd has made it available/accessible Dynulta, for the first time in India.