…………………….catching up on recent FDA approvals
The FDA recently approved a new Sub-q therapy, Yorvipath (palopegteriparatide, developed as TransCon PTH) from Ascendis Pharma, to treat hypoparathyroidism in adults. Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs. The disease affects an estimated 70,000 to 90,000 people in the United States.
Yorvipath is a once daily subcutaneous therapy. Dosage is individualized with the recommended starting dosage of 18 mcg once daily and is then titrated in 3 mcg increments or decrements with the goal of maintaining serum calcium within the normal range without the need for active vitamin D (e.g., calcitriol) or therapeutic calcium doses (elemental calcium >600 mg/day). Calcium supplementation sufficient to meet daily dietary requirements may be continued.
Patients must be monitored daily for clinical signs and symptoms of hypocalcemia or hypercalcemia.
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Ascendis Pharma suggests a $150,000 to $160,000 wholesale acquisition price with about a $130,000 net price.
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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.
