FROM THE FDA
The parathyroid hormone Natpara has been approved to manage hypocalcemia in patients with hypoparathyroidism, according to a press release from the Food and Drug Administration.
In the phase III REPLACE study, 124 participants were randomly assigned Natpara or a placebo to determine whether Natpara can be used as a substitute for or help reduce the amount of active forms of vitamin D or oral calcium taken by participants. Of patients treated with Natpara, 42% achieved normal blood calcium levels, while 3% of patients achieved normal blood calcium levels on the placebo, the FDA said.
“People with hypoparathyroidism have limited treatment options and face challenging symptoms that can severely impact their quality of life. This product offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D,” Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in the press release.
Because of instances of bone cancer in rat studies, Natpara carries a warning and is only recommended for patients whose hypocalcemia cannot be controlled by other means. Common side effects include sensations of tingling, low blood calcium, headache, high blood calcium, and nausea.
Hypoparathyroidism is a rare disease, only affecting about 60,000 people in the United States. It occurs when loss of function of the parathyroid glands causes the body to secrete abnormally low levels of parathyroid hormone, which helps regulate calcium and phosphorus levels in the body; surgical removal of the parathyroid glands is another cause as is, and more rarely, autoimmune or congenital diseases, according to the FDA.
Natpara is manufactured by NPS Pharmaceuticals, Inc.
