Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that Natpara® (parathyroid hormone) for injection is now available in the United States. The U.S. Food and Drug Administration (FDA) approved Natpara as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism on January 23, 2015. Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute post-surgical hypoparathyroidism.
Natpara will be available through a Risk Evaluation and Mitigation Strategy (REMS) Program and a limited network of specialty pharmacies. Eligible patients who are prescribed Natpara will have access to patient support services through NPS Advantage. These services include access to NPS Advantage Care Coordinators who can provide: information about Natpara, insurance authorization, appeals and financial assistance; assistance with ordering products; and, connect patients with a Nurse Educator.
"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 the Gastrointestinal and Internal Medicines Business Unit at Shire. "The Natpara launch is an example of how we are addressing a significant unmet patient need and expanding our rare disease offerings."