FDA approves Yorvipath (palopegteriparatide) as the first and only treatment for hypoparathyroidism in adults- Ascendis A/S

Yorvipath is a prodrug of parathyroid hormone (PTH[1-34]), administered once daily, designed to provide continuous exposure to released PTH over the 24-hour dosing period. Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs and affects an estimated 70,000 to 90,000 people in the United States.

At launch, Ascendis plans to offer a suite of patient services for Yorvipath through its U.S. Ascendis Signature Access Program (A.S.A.P.), including support navigating the treatment journey and financial assistance programs for eligible patients.

The FDA based its approval of Yorvipath on their review of the clinical package for TransCon PTH (palopegteriparatide) submitted with the Company’s New Drug Application, including data from the global Phase II PaTH Forward and Phase III PaTHway trials.

" The consequences of hypoparathyroidism on the health and quality of life of our patients can be extraordinarily debilitating,” said Lynn Kohlmeier, M.D., endocrinologist at Spokane Osteoporosis & Endocrinology, Chair of the Medical Advisory Board of the HypoPARAthyroidism Association, and an investigator in the PaTHway Trial. “The ability to address the underlying cause of this disease is crucial and will be an important advancement for our patients with hypoparathyroidism.”

Ascendis is completing manufacturing of commercial product for the U.S. market and anticipates initial supply will be available in the first quarter of 2025. In addition, Ascendis plans to request FDA approval to commercialize existing manufactured product, which, if approved, could be introduced in the U.S. in the fourth quarter of 2024.