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Monday, the FDA approved Ascendis Pharma A/S’ (NASDAQ:ASND) Yorvipath (palopegteriparatide; developed as TransCon PTH) for hypoparathyroidism in adults.
Hypoparathyroidism is a rare, treatable condition that occurs when a person has low levels of parathyroid hormone in the blood. This causes low calcium levels (hypocalcemia) and high phosphorous levels.
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Hypoparathyroidism impacts multiple organs and affects an estimated 70,000 to 90,000 people in the U.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.
At launch, Ascendis plans to offer a suite of patient services for Yorvipath through its U.S. Ascendis Signature Access Program.
The approval was based on 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.
Ascendis is completing the manufacturing of a commercial product for the U.S. market and anticipates an initial supply will be available in the first quarter of 2025.
In addition, Ascendis plans to request FDA approval to commercialize an existing manufactured product, which, if approved, could be introduced in the U.S. in the fourth quarter of 2024.
In May, the FDA extended the review date for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism, stating the information Ascendis Pharma submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH constituted a major amendment.
Just a year ago, the FDA issued a complete response letter (CRL) for TransCon PTH (palopegteriparatide) New Drug Application (NDA) for hypoparathyroidism.
In the letter, the FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product.
In October 2022, Takeda Pharmaceutical Co Ltd (NYSE:TAK) terminated the manufacturing of Natpar/Natpara (parathyroid hormone) for Injection globally at the end of 2024 due to unresolved supply issues specific to the product.
Takeda said it will not re-commercialize Natpara in the U.S. and will discontinue manufacturing Natpar globally.
Until the end of 2024, Takeda said its key priority is maintaining treatment continuity for patients currently receiving Natpar/Natpara, subject to available supply, including those enrolled in the U.S. Special Use Program and all patients receiving Natpar in Europe and other regions.
Beyond 2024, Takeda intends to supply available doses until inventory is depleted or expired.
Price Action: ASND stock is up 4.45% at $132.62 at last check Monday.
Photo via Shutterstock
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