Ascendis Pharma has announced the commercial availability of Yorvipath (palopegteriparatide) in the United States, marking a significant advancement in the treatment of hypoparathyroidism in adults. Yorvipath is the first and only FDA-approved medication designed to address the underlying cause of this condition by providing continuous exposure to active parathyroid hormone (PTH) over a 24-hour period through a once-daily injection.
Dedicated Support for Patients
To ensure patients receive comprehensive care, Ascendis Pharma has established the Ascendis Signature Access Program, which includes a dedicated Yorvipath team. This program offers a range of services, including clinical education, assistance with prior authorization, injection training, and co-pay support for eligible patients.
Clinical Trial Success
The approval and subsequent launch of Yorvipath are supported by robust clinical trial data. A Phase 3 trial, known as PaTHway, demonstrated that 93% of patients treated with Yorvipath achieved independence from both active vitamin D and therapeutic doses of elemental calcium. This outcome was associated with a clinically meaningful reduction in their daily pill burden.
The PaTHway trial was a 26-week, randomized, double-blind, placebo-controlled study that assessed the efficacy and safety of palopegteriparatide in 84 adults with chronic hypoparathyroidism. The results, published in the Journal of Bone and Mineral Research, highlighted the drug's efficacy, safety, and tolerability as a once-daily PTH replacement therapy.
Safety Profile and Adverse Reactions
While Yorvipath offers a significant advancement in treatment, it is important to note potential adverse reactions. The most common adverse reactions reported in clinical trials included injection site reactions (39%), vasodilatory signs and symptoms (28%), headache (21%), diarrhea (10%), back pain (8%), hypercalcemia (8%), and oropharyngeal pain (7%).
Important Safety Information
Yorvipath carries warnings and precautions, including the risk of unintended changes in serum calcium levels, serious hypercalcemia, and serious hypocalcemia. There is also a potential risk of osteosarcoma, as observed in animal studies with PTH analogs. The drug is contraindicated in patients with severe hypersensitivity to palopegteriparatide or any of its excipients.
Addressing an Unmet Need
Hypoparathyroidism is an endocrine disease characterized by insufficient levels of parathyroid hormone (PTH), which is crucial for regulating calcium and phosphate balance in the body. Individuals with this condition may experience a range of severe and potentially life-threatening complications. Ascendis Pharma's Yorvipath aims to address this unmet medical need by providing a PTH replacement therapy that mimics the natural hormone patterns.
Looking Ahead
The commercial availability of Yorvipath in the United States represents a significant milestone for the hypoparathyroidism community. With its unique mechanism of action and comprehensive patient support program, Yorvipath offers a new approach to managing this challenging condition and improving the quality of life for affected individuals.
