The U.S. Food and Drug Administration today approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States.
Hypoparathyroidism occurs when the body secretes abnormally low levels of parathyroid hormone, which helps regulate calcium and phosphorus levels in the body.
Hypoparathyroidism is caused by loss of function of the parathyroid glands and occurs most commonly as a result of surgical removal of the parathyroid glands and more rarely as a result of autoimmune or congenital diseases. Patients with hypoparathyroidism can experience numbness, tingling, muscle twitching, spasms or cramps, abnormal heart rhythm, and seizures as a consequence of low blood calcium levels.
Hypoparathyroidism is also associated with long-term complications such as kidney damage, kidney stones, development of cataracts and calcification of soft tissues.
Natpara, a hormonal injection administered once daily, helps to regulate the body’s calcium levels. The FDA granted Natpara orphan drug designation because it is intended to treat a rare disease.
For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431358.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery