The FDA has approved Ascendis Pharma’s palopegteriparatide, branded Yorvipath, as the first treatment for hypoparathyroidism in adults.
Yorvipath is a prodrug of parathyroid hormone (PTH[1-34]) designed to provide continuous exposure to PTH over a 24-hour period with once-daily administration. Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, impacting multiple organs and affecting an estimated 70,000 to 90,000 individuals in the United States.
The approval of Yorvipath was based on clinical data from the phase 2 PaTH Forward and phase 3 PaTHway trials, which were included in Ascendis Pharma’s NDA. The drug was initially rejected by the agency in 2023, with the FDA citing concerns related to the manufacturing control strategy for variability of delivered dose in the drug/device combination product. After meeting with the FDA, Ascendis resubmitted its NDA in November. While the agency pushed back its review last May, with this approval, Yorvipath becomes the only available treatment specifically targeting the underlying cause of hypoparathyroidism.
Ascendis Pharma is preparing for the commercial release of Yorvipath in the U.S., with the initial supply anticipated in the first quarter of 2025. In conjunction with the product launch, Ascendis plans to offer patient services through its U.S. Ascendis Signature Access Program (A.S.A.P.), including support for navigating treatment and financial assistance for eligible patients.
