FDA approves Bone Care’s Hectorol for treatment of kidney disease

Middleton, Wis. -- Bone Care International, Inc. announced Monday the U.S. Food and Drug Administration approved a new indication and strength for Hectorol (doxercalciferol) Capsules. Hectorol, a pro-hormone vitamin D2 analog, is currently approved for the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients in the United States, and is now approved for the treatment of SHPT that develops in the earlier stages (stages three and four) of chronic kidney disease (CKD).

Current therapies for SHPT are primarily targeted for use in the more than 300,000 dialysis (stage five CKD) patients in the United States. However, this disease frequently develops during the earlier stages of CKD, before patients require dialysis. It is estimated that there are more than eight million stage three and four CKD pre-dialysis patients in the United States, many of whom have developed SHPT.

SHPT initially develops due to the CKD patient’s inability to produce adequate levels of active vitamin D hormone. As CKD progresses, vitamin D hormone levels decline with SHPT typically characterized by a subsequent decrease in calcium levels along with elevated parathyroid hormone (PTH) and phosphorus levels. If left untreated, SHPT can eventually result in
cardiovascular disease, reduced immune system function, muscle weakness and bone mineral loss and fractures.

“We are enthusiastic about this new indication for Hectorol Capsules as it provides physicians and patients with the first oral pro-hormone vitamin D2 analog therapy for early treatment of SHPT in pre-dialysis patients, a large population with significant unmet medical needs,” said Paul Berns, president and chief executive officer, Bone Care International.

The National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines recommend the treatment of SHPT before CKD patients’ progress to dialysis. “The new indication for Hectorol 0.5 mcg Capsules provides the nephrology community with a safe and effective way to treat SHPT in pre-dialysis patients (stages three and four) in a manner consistent with the NKF K/DOQI clinical practice guidelines for bone metabolism and disease in CKD,” said Jeffrey Freitag, vice president of research and development, Bone Care International.

Bone Care International is a Middleton-based pharmaceutical company focused on improving patient outcomes by delivering vitamin D hormone therapies.