FDA Approves Natpara® for Hypoparathyroidism02/2015
January 23, 2015—The U.S. Food and Drug Administration (FDA) has approved Natpara® (parathyroid hormone) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH).
About three-quarters of the people with hypoparathyroidism had thyroid surgery, usually for thyroid cancer, and experienced loss or damage to their parathyroid glands, significantly affecting their calcium levels.
Natpara® is expected to be available in the second quarter of 2015 in the United States.
In Europe, the European Medicines Agency (EMA) has validated and initiated its review of NPS Pharma’s marketing authorization application for Natpar™.
Natpara® is a bioengineered replica of human PTH. It is manufactured by NPS Pharma. It is recommended only for patients who cannot be well controlled on calcium supplements and active forms of vitamin D alone.
At the FDA hearing on Natpara® in 2014, ThyCa Executive Director Gary Bloom spoke in support of the FDA approval of Natpara®. Each ThyCa Conference has sessions on hypoparathyroidism, a challenging disorder requiring lifelong management.
ThyCa’s web site will add more information about Natpara® in the future.