FDA grants approval to Natpara

SILVER SPRING, Md. — The Food and Drug Administration last week approved Natpara (parathyroid horomone), which is indicated to control hypocalcemia — low blood calcium levels — in patients who have hypoparathyroidism.

 

Hypoparathyroidism happens when the body secretes abnormally low levels of parathyroid hormone, which plays an important role in regulating calcium and phosphorus levels in the body. The disease affects 60,000 people in the United States, according to the FDA.

 

Patients who have hypoparathyroidism may experience numbness, tingling, muscle twitching, spasms or cramps, abnormal heart rhythm and seizures resulting from low blood calcium levels. The disease is also associated with such long-term complications as kidney damage, kidney stones, cataracts and soft tissue calcification. Natpara is injected once a day, and helps to regulate the body's calcium levels. The FDA has given the medication and orphan drug designation because it is used to treat a rare disease. 

 

“People with hypoparathyroidism have limited treatment options and face challenging symptoms that can severely impact their quality of life,” said Jean-Marc Guettier, M.D., director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research. “This product offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D.”

 

Natpara is manufactured by NPS Pharmaceuticals.