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news.Irish biopharmaceutical firm Shire has launched Natpara (parathyroid hormone) for Injection in the US as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
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Due to the potential risk of osteosarcoma, Natpara is indicated only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone.
The company said that Natpara was not examined in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute post-surgical hypoparathyroidism.
The injection will be available through a Risk Evaluation and Mitigation Strategy (REMS) Program and a limited network of specialty pharmacies.
Shire Gastrointestinal and Internal Medicines Business Unit head Roger Adsett said: "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.
"The Natpara launch is an example of how we are addressing a significant unmet patient need and expanding our rare disease offerings."
According to the company, eligible patients who are prescribed Natpara will have access to patient support services through NPS Advantage.
Currently, Natpara is available in four dosage strengths 25mcg, 50mcg, 75mcg and 100mcg.