has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH (palopegteriparatide) to treat hypoparathyroidism in adults.
Hypoparathyroidism is a rare endocrine disease characterised by insufficient levels of the parathyroid hormone, affecting multiple organs.
A prodrug of parathyroid hormone (PTH[1-34]), YORVIPATH is administered once a day. It aims to provide a continuous exposure to released PTH over a dosing period of 24 hours.
Upon the launch of YORVIPATH, Ascendis intends to introduce a comprehensive suite of patient services through its US Ascendis Signature Access Program.
These services assist patients in navigating their treatment journey and offer financial assistance to those eligible.
The latest approval for YORVIPATH was based on a thorough review of the clinical package for TransCon PTH (palopegteriparatide), submitted with the new drug application.
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By GlobalDataThe package included findings from the global Phase II PaTH Forward and Phase III PaTHway trials.
Ascendis is currently finalising the manufacturing of the commercial product for the US market. The initial supply will become available in the first quarter of 2025.
The company also plans to request FDA approval to commercialise the existing manufactured product. If approved, this could allow for an earlier introduction in the US market by the fourth quarter of 2024.
Ascendis Pharma president and CEO Jan Mikkelsen said: 鈥淔DA approval of our second TransCon product, YORVIPATH, reflects our values and dedication to following the science to help patients, as well as our unwavering commitment these past years to addressing the significant unmet medical needs of the hypoparathyroidism community in the US.
鈥淲e are deeply grateful to patients, clinicians and advocates for their many contributions to this important milestone.鈥�
In July 2024, the company entered an exclusive distribution agreement with Pendopharm to offer the hypoparathyroidism treatment TransCon PTH in the Canadian market.
