Shire's Hypocalcemia Drug Launches in US

Shire’s self-administered parathyroid hormone (Natpara) to control hypocalcemia in patients with hypoparathyroidism is now available in the United States.

The FDA approved Natpara in January 2015 as an adjunct to calcium and vitamin D therapy. The bioengineered replica of human parathyroid hormone is self-administered once a day by subcutaneous injection, and it is available in 4 dosage strengths: 25 mcg, 50 mcg, 75 mcg, and 100 mcg.

“We are proud to introduce Natpara because it fulfills a long-term unmet need for a subset of an already rare patient population who cannot be well-controlled on the standard of care, and until now, did not have an FDA-approved parathyroid hormone to help treat their condition,” said Roger Adsett, head of Shire’s Gastrointestinal and Internal Medicines Business Unit, in a press release. “The Natpara launch is an example of how we are addressing a significant unmet patient need and expanding our rare disease offerings.”

Because of the potential risk of osteosarcoma associated with Natpara, the therapy is only available through a Risk Evaluation and Mitigation Strategy program and a limited network of specialty pharmacies. It is only recommended for patients who cannot be well controlled on calcium supplements and active forms of vitamin D alone, and it was not studied in those with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute post-surgical hypoparathyroidism.

The most common side effects associated with Natpara include a tingling, tickling, or burning feeling on the skin, as well as headache and nausea.