Abbott Laboratories submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Zemplar Capsules, its investigational oral therapy for earlier treatment of secondary hyperparathyroidism (SHPT). The capsule form of Zemplar would provide the potential for earlier intervention and treatment for SHPT to patients with early-stage chronic kidney disease, who do not yet require dialysis or transplantation, an Abbott release said.
The injectable form of Zemplar, a third-generation vitamin D compound, has been available since 1998 and is the standard of care for the prevention and treatment of SHPT in the dialysis patient population. More than 1.5 million patients worldwide are being treated for end-stage renal disease (ESRD) with dialysis therapy. ESRD is an advanced stage of chronic kidney disease that requires some form of renal replacement therapy, including dialysis or transplantation. SHPT is a major complication associated with chronic kidney disease, which affects bones and vital organs.
"Early identification and treatment of secondary hyperparathyroidism play an important role in managing chronic kidney disease. To date, physicians have had limited treatment options to manage earlier-stage patients," said Daniel W Coyne, associate professor of medicine, Washington University School of Medicine, and lead investigator for Zemplar Capsules phase III clinical studies.
"The New Drug Application for Zemplar Capsules is in line with our commitment to pursue five regulatory submissions during 2004, and further showcases Abbott's robust pipeline for drug development that has the potential to address many critical health issues, including kidney disease, cancer, arthritis and HIV/AIDS," said Jeffrey M Leiden, president and chief operating officer, Pharmaceutical Products Group, Abbott Laboratories.
The incidence and prevalence of kidney disease have doubled in the last 10 years and are expected to continue to grow. New scientific evidence and treatment guidelines recently published by the National Kidney Foundation are changing the way doctors approach early-stage kidney disease and emphasize the importance of identification and treatment earlier in the progression of the disease, the release says.
Two major risk factors for kidney disease are diabetes and hypertension, which account for two-thirds of new cases of kidney disease each year. Minority populations bear a disproportionate burden. Research from the National Institutes of Health finds that African-Americans are six times more likely than Caucasians to develop hypertension-related kidney failure.