Danish drugmaker Ascendis Pharma has received the US Food and Drug Administration (FDA) approval for Yorvipath (palopegteriparatide) for the treatment of hypoparathyroidism in adults.
Yorvipath is a prodrug of parathyroid hormone (PTH [1-34]), administered once daily to provide continuous exposure to released PTH over the 24-hour dosing period.
Hypoparathyroidism is a rare endocrine disease caused by inadequate levels of parathyroid hormone that impacts multiple organs.
Yorvipath is not indicated for patients with severe hypersensitivity to palopegteriparatide or any of its excipients.
Parathyroid hormone analogues are associated with hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria.
Ascendis Pharma president and CEO Jan Mikkelsen said: “FDA 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 United States.
“We are deeply grateful to patients, clinicians, and advocates for their many contributions to this important milestone.”
The FDA approval of Yorvipath is based on the review of the clinical package for TransCon PTH (palopegteriparatide), submitted with the company’s New Drug Application.
It also includes data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials.
Ascendis is completing the manufacturing of commercial products for the US market and planning to begin initial supply in the first quarter of 2025.
The company also plans to seek FDA approval to commercialise existing manufactured products, which could be launched in the US in the fourth quarter of 2024, if approved.
Ascendis intends to provide patient services for Yorvipath through its US Ascendis Signature Access Program (ASAP), to help eligible patients with financial assistance programs.
PaTHway Trial investigator Lynn Kohlmeier said: “The consequences of hypoparathyroidism on the health and quality of life of our patients can be extraordinarily debilitating.
“The ability to address the underlying cause of this disease is crucial and will be an important advancement for our patients with hypoparathyroidism.”
Earlier this year, Specialised Therapeutics Asia (ST), an independent biopharmaceutical company, entered into an exclusive distribution agreement with Ascendis Pharma.
The distribution agreement involves regions, including Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam.
