The U.S. Food and Drug Administration (FDA) recently approved the drug Natpara, manufactured by NPS Pharaceuticals, Inc., to treat low blood calcium levels in patients with hypoparathyroidism.
“People with hypoparathyroidism have limited treatment options and face challenging symptoms that can severely impact their quality of life,” Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said. “This product offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D.”
Hypoparathyroidism is a rare disease that results from the body secreting abnormally low levels of the parathyroid hormone, usually after surgical removal of the parathyroid glands, or because of autoimmune or congenital processes. It is estimated that approximately 60,000 people in the United States are affected by hypoparathyroidism.
Blood calcium levels can be affected because the parathyroid hormone helps regulate calcium and phosphorus in the body.
Natpara is a once-daily injection that has been given the orphan drug designation by the FDA. A study of 124 participants completed before the FDA’s approval found that 42 percent of patients treated with Natpara reported normal blood calcium levels when compared to participants in the trial treated with a placebo.