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FDA Approves New Drug for Hypoparathyroidism, a Rare Disorder

The U.S. Food and Drug Administration has approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism. Yorvipath was not studied in adults with acute post-surgical hypoparathyroidism.

Hypoparathyroidism is a rare disease most often caused by damage to the parathyroid glands from surgery or autoimmune disease. Patients with hypoparathyroidism have low levels of parathyroid hormone (PTH), which leads to hypocalcemia (blood calcium levels that are too low).

Yorvipath’s labeling includes warnings for a potential risk of risk of unintended changes in serum calcium levels related to number of daily injections and total delivered dose, serious hypocalcemia and hypercalcemia (blood calcium levels that are too high), osteosarcoma (a rare bone cancer) based on findings in rats, orthostatic hypotension (dizziness when standing), and a risk of a drug interaction with digoxin (a medicine for certain heart conditions). Consult the prescribing information for more details about Yorvipath’s risks. Adverse reactions occurring in more than 15% of patients and more commonly on Yorvipath than on placebo were injection site reactions, vasodilatory signs and symptoms (e.g., decreased blood pressure and dizziness), and headache.

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