HEALTH DESK
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.
Disease or Condition
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).
Patients with hypoparathyroidism are typically treated with active vitamin D and calcium to raise blood calcium into the low-normal range and can require large doses of calcium taken more than once a day. Symptoms of hypoparathyroidism vary depending on blood calcium levels, and can include tingling or numbness in the fingertips, toes, and lips; muscle cramps and spasms; and seizures.
Effectiveness
The effectiveness of Yorvipath was evaluated in a 26-week, randomized, double-blind, placebo-controlled trial that enrolled 82 adults with hypoparathyroidism. Prior to randomization, all subjects underwent an approximate 4-week screening period in which calcium and active vitamin D supplements were adjusted to achieve an albumin-corrected serum calcium concentration between 7.8 and 10.6 mg/dL, a magnesium concentration ≥1.3 mg/dL and below the upper limit of the reference range, and a 25(OH) vitamin D concentration between 20 to 80 ng/mL. During the double-blind period, subjects were randomized to either Yorvipath (N = 61) or placebo (N= 21), at a starting dose of 18 mcg/day, co-administered with conventional therapy (calcium and active vitamin D). Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. At the end of the trial, 69% of the patients in the Yorvipath group compared to 5% of the patients in the placebo group were able to maintain their calcium level in the normal range, without needing active vitamin D and high doses of calcium (calcium dose ≤ 600 mg/day).
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Safety Information
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.
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-hypoparathyroidism-rare-disorder