FDA Approves Yorvipath (palopegteriparatide) for Hypoparathyroidism
Key Insights
The FDA has approved Yorvipath (palopegteriparatide) as a treatment for adults with hypoparathyroidism (search), offering a new therapeutic option.
Yorvipath is developed by Ascendis Pharma using their TransCon (search) technology, designed to provide a potentially best-in-class therapy.
The approval follows an extension of the FDA review period to fully assess the New Drug Application (NDA) for palopegteriparatide.
The U.S. Food and Drug Administration (FDA) has approved Yorvipath (palopegteriparatide) for the treatment of adults with hypoparathyroidism (search). Developed by Ascendis Pharma, this approval marks a significant advancement in addressing the unmet needs of patients with this endocrine disorder.
The approval comes after the FDA extended the review period for the New Drug Application (NDA) to allow for a comprehensive assessment of the submitted data. Ascendis Pharma actively collaborated with the FDA throughout the review process to ensure all requests were addressed.
Addressing Hypoparathyroidism
Hypoparathyroidism (search) is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH), leading to decreased calcium levels in the blood. Current treatments often involve calcium and vitamin D supplementation, which may not fully address the underlying hormonal deficiency.
Yorvipath (palopegteriparatide) offers a new approach by providing a PTH replacement therapy. Ascendis Pharma's TransCon (search) technology is designed to create therapies that potentially offer best-in-class treatment options. The company's commitment is reflected in their core values centered on patients, science, and passion.
Ascendis Pharma's Perspective
Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer, stated the company's commitment to bringing TransCon (search) PTH to adults with hypoparathyroidism (search) in the United States, who face an urgent need for new treatments.
Ascendis Pharma is a biopharmaceutical company focused on applying its innovative TransCon (search) technology platform to develop therapies. Headquartered in Copenhagen, Denmark, Ascendis Pharma has additional facilities in Europe and the United States.