Zemplar capsules for earlier treatment of kidney disease complication get approval
The US FDA has approved Zemplar (paricalcitol) Capsules of Abbott, an oral, activated vitamin D therapy for prevention and treatment of secondary hyperparathyroidism (SHPT). Zemplar Capsules are indicated for the prevention and treatment of SHPT in stages three and four chronic kidney disease (CKD) patients, before the need for dialysis or transplantation.
"We are pleased to bring a significant and convenient treatment advance to pre-dialysis patients with secondary hyperparathyroidism in stage three and four chronic kidney disease," said Eugene Sun, vice president, Global Pharmaceutical Clinical Development, Abbott.
SHPT is a major complication associated with CKD 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.
Zemplar Capsules are a new, oral formulation of Zemplar Injection, which was introduced in 1998 and is the most widely-used activated vitamin D for the prevention and treatment of SHPT among dialysis patients.