FDA approves Natpara injection for hypocalcemia

FDA has approved parathyroid hormone (Natpara, NPS Pharma) once-daily injection to control hypocalcemia in patients with hypoparathyroidism.

Hypoparathyroidism is a rare endocrine disorder of absent parathyroid hormone secretion and abnormal mineral metabolism characterized by hyperphosphatemia, or high phosphate levels, and hypocalcemia, or low calcium levels.

Hypoparathyroidism occurs most commonly as a result of surgical injury or removal of parathyroid glands. Signs and symptoms of hypoparathyroidism include tingling sensations in finger and toes, muscles aches, tiredness, anxiety, seizures, and headaches. Patients may also develop serious long-term complications such as kidney damage, kidney stones, and cataracts.

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Natpara is approved as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. The drug acts as a parathyroid hormone analog to regulate the body’s calcium levels. Natpara was granted orphan drug designation by FDA.

“Natpara is a significant advance in the care of hypoparathyroidism and we are very pleased to offer the first and only parathyroid hormone approved for people living with this rare disorder,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals.

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The safety and efficacy of Natpara were assessed in a clinical trial of 124 participants who were randomly assigned to receive Natpara or placebo. Results showed 42% of patients treated with Natpara achieved normal blood calcium levels on reduced doses of calcium supplements and active forms of vitamin D, compared to 3% of participants taking placebo.

The most common side effects associated with the use of Natpara included tingling, tickling, pricking or burning sensations; low blood calcium; headache; high blood calcium; and nausea. Because of the potential risk of osteosarcoma, or bone cancer, Natpara carries a boxed warning and is only recommended for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. Natpara will be made available through a Risk Evaluation and Mitigation Strategy (REMS) program to lower the potential risk of osteosarcoma.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.