Rockwell Medical, Inc., a biopharma company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with treatments for iron replacement, hyperparathyroidism and hemodialysis, updated on May 4 its development for the commercial launch of Calcitriol, the company’s FDA approved active vitamin D injection for the management of hypocalcemia in patients undergoing chronic renal dialysis.
According to a press release, Rockwell Medical’s contract manufacturer found that one of the excipients used in the completed finalized product for commercial sale was out of specification for stability, which has no connection to the active pharmaceutical ingredient in Calcitriol – supplied by another manufacturer. Rockwell is now working closely with its contract manufacturer to solve the issue, which has prompted the company to move its near-term expectation for the commercial launch of Calcitriol in the United States to the third quarter of 2016.
According to the National Kidney Foundation, CKD is estimated to affect 26 million Americans and includes all conditions that affect correct kidney function and decrease ability to keep one healthy. CKD can be triggered by existing conditions that include diabetes, high blood pressure and other disorders. Only early detection and treatment can prevent disease deterioration. Upon progression CKD may eventually lead to kidney failure, which requires life-long dialysis treatments or kidney transplant.
When a CKD patient loses about 85% to 95% of kidney function, and a doctor confirms that the loss will continue until the end of the patient’s life, renal dialysis will likely be necessary to keep the body in balance. Dialysis aids by removing waste, salt and extra water and by manintaining safe level of certain chemicals in your blood – like potassium, sodium or bicarbonate. The procedure also helps control blood pressure.
The company’s generic drug calcitriol (active vitamin D) is indicated for the treatment of secondary hyperparathyroidism in dialysis patients, whereas Calcitriol injection is indicated for the management of hypocalcemia in patients undergoing chronic renal dialysis. Studies have shown Calcitriol to significantly reduce elevated parathyroid hormone levels, which in turn has been shown to result in an improvement of renal osteodystrophy.