Yorvipath FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 12, 2024.
FDA Approved: Yes (First approved August 9, 2024)
Brand name: Yorvipath
Generic name: palopegteriparatide
Dosage form: Injection
Previous Name: TransCon PTH
Company: Ascendis Pharma, Inc.
Treatment for: Hypoparathyroidism
Yorvipath (palopegteriparatide) is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults.
- Hypoparathyroidism is a rare endocrine disorder characterized by deficient or absent parathyroid hormone, a hormone that plays a critical role in controlling calcium, phosphate and calcitriol (active vitamin D) levels in the blood and bone.
- Yorvipath is a long-acting, once-daily hormone replacement therapy designed to restore physiologic levels of parathyroid hormone to address both the short-term symptoms and long-term complications of hypoparathyroidism.
- FDA approval of Yorvipath was based on a review of the clinical package for TransCon PTH (palopegteriparatide) submitted with the Company’s New Drug Application, including data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials.
- Yorvipath is administered by subcutaneous injection once daily.
- Warnings and precautions associated with Yorvipath include unintended changes in serum calcium levels when exceeding recommended once daily dosage, serious hypercalcemia and hypocalcemia, potential risk of osteosarcoma, orthostatic hypotension, and risk of digoxin toxicity with concomitant use of digitalis compounds.
- Common adverse reactions (occurring in ≥5% of patients) include injection site reactions, vasodilatory signs and symptoms, headache, diarrhea, back pain, hypercalcemia, and oropharyngeal pain.
Development timeline for Yorvipath
Further information
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