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FDA Approves New Indication For Hectorol (Doxercalciferol), Pro-Hormone Vitamin D2 Analog for Use in Pre-Dialysis Chronic Kidney Disease

MIDDLETON, WI -- April 26, 2004 -- Bone Care International, Inc. (Nasdaq: BCII) today announced that the U.S. Food and Drug Administration approved a new indication and strength for Hectorol® (doxercalciferol) Capsules. Hectorol, a novel pro-hormone vitamin D2 analog, currently approved for the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients in the United States, is now approved for the treatment of SHPT that develops in the earlier stages (Stages 3 and 4) of chronic kidney disease (CKD) prior to dialysis.

Current therapies for SHPT are primarily targeted for, or limited to, use in the more than 300,000 dialysis (Stage 5 CKD) patients in the United States. However, this disease frequently develops in the earlier stages of CKD before patients require dialysis, and it is estimated that there are more than eight million Stage 3 and 4 CKD pre-dialysis patients in the United States, many of whom have developed SHPT. "The approval of our supplemental new drug application (sNDA) for Hectorol 0.5 mcg Capsules in pre-dialysis CKD patients reflects the outstanding efforts of our employees and their commitment to developing therapeutic products to serve patients," said Paul L. Berns, president and chief executive officer at Bone Care International. "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."

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 3 and 4) in a manner consistent with the NKF K/DOQI clinical practice guidelines for bone metabolism and disease in CKD," said Jeffrey J. Freitag, M.D., vice president of research and development at Bone Care International.

Secondary Hyperparathyroidism

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. "Hectorol 0.5 mcg Capsules address the CKD-related active vitamin D hormone deficiency that triggers the onset of SHPT. This was demonstrated in the clinical setting through the effective and safe management of SHPT in Stages 3 and 4 CKD patients; Hectorol significantly reduced PTH while maintaining calcium and phosphorus targets," said Freitag.

"It is important to recognize that depletion of vitamin D hormone in CKD patients is a significant disorder that can lead to serious clinical consequences," said Jill Lindberg, M.D., a lead investigator for the Hectorol Phase III clinical trials and director of the Metabolic Bone and Stone Clinic, New Orleans Nephrology Associates, and associate clinical professor of medicine at Tulane University. "Up until now, the only available vitamin D treatment for SHPT in pre-dialysis patients was calcitriol; a first generation vitamin D3 sterol often associated with elevations in serum calcium and calcium-phosphorus product."

Correcting vitamin D hormone deficiency due to kidney disease is a vital component of the treatment strategy for SHPT in Stages 3, 4 and 5 CKD. According to Shaul G. Massry, M.D., professor of medicine at KECK School of Medicine, University of Southern California, and Work Group Chair, K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in CKD, "Vitamin D hormone therapy is an important aspect of our K/DOQI clinical practice guidelines. Innovative therapies that improve the treatment of kidney disease complications related to bone and mineral metabolism, such as the harmful effects caused by vitamin D hormone deficiency, are important for maintaining the health and well-being of these patients."

Hectorol is a useful tool to help practitioners and patients meet recommended target treatment goals. "Hectorol is an important addition to our armamentarium of therapeutic solutions to help clinicians achieve the NKF K/DOQI guideline treatment goals designed to protect the long-term health of CKD patients," said Mark Williams, M.D., a lead investigator for the Hectorol Phase III clinical trials and director of dialysis at Beth Israel Deaconess Medical Center in Boston and associate clinical professor of medicine at Harvard University. "Hectorol Capsules effectively lowered PTH in Stages 3 and 4 CKD patients with no increase in the incidence of hypercalcemia or hyperphosphatemia compared to placebo treatment. Hectorol is an effective treatment option safe enough to use when SHPT really begins."

Regarding Hectorol

In clinical trials in pre-dialysis CKD patients with SHPT, Hectorol 0.5 mcg Capsules were safe and effective in reducing PTH while maintaining calcium, phosphorus and calcium-phosphorus product in men and women with Stages 3 and 4 CKD.

Importantly, 74 percent of pre-dialysis CKD patients treated with Hectorol 0.5 mcg Capsules achieved a greater than or equal to 30 percent reduction in PTH and the average reduction in PTH was 46 percent. These results were statistically significant compared to placebo results. In terms of safety data, the incidences of hypercalcemia and hyperphosphatemia were similar to placebo therapy, and no episodes of hypercalciuria were observed. Vitamin D therapies such as Hectorol regulate blood calcium at levels required for essential body functions. Based on the mechanism of action, vitamin D should not be given to patients with a tendency towards hypercalcemia or evidence of vitamin D toxicity. Oversuppression of PTH, increases in serum calcium, serum phosphorus and urinary calcium can occur with vitamin D therapy. These potential adverse effects should be managed by regular patient monitoring and appropriate dosage adjustments.


SOURCE: Bone Care International, Inc.

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