Abbott Laboratories is celebrating winning US Food and Drug Administration approval for Zemplar Capsules (paricalcitol) for both the prevention and treatment of secondary hyperparathyroidism – a serious complication of chronic kidney disease.
Abbott first filed the new-generation vitamin D compound with the US regulator last summer [[03/08/04h]], and approval is based on the results of three Phase III trials. Ninety-one percent of patients treated with Zemplar Capsules had significant and sustained reduction in levels of the parathyroid hormone associated with SHPT, compared to only 13% of placebo patients, after 24 weeks of therapy. The product is specifically cleared to treat patients with chronic kidney disease before the need for dialysis or transplantation.
SHPT is a major complication associated with chronic kidney disease that can detrimentally impact bones and other vital organs, including the heart, muscles and nerves if left untreated. It can occur when kidneys lose their ability to activate vitamin D obtained through diet and other sources. One in nine adults in the US, or 20 million people, have CKD and another 20 million are at risk for developing CKD from underlying causes such as diabetes and hypertension.