EU Approves Ascendis’ Yorvipath for Hypoparathyroidism

Rare Daily Staff

The European Commission granted Ascendis Pharma’s marketing authorization for Yorvipath, as replacement therapy for the treatment of adults with chronic hypoparathyroidism.

Hypoparathyroidism is an endocrine disease caused by insufficient levels of PTH, the primary regulator of calcium/phosphate balance in the body, acting directly on bone and kidneys and indirectly on intestines. Hypoparathyroidism is considered chronic if it persists for more than six months following surgery. Individuals with hypoparathyroidism may experience a range of severe and potentially life-threatening short-term and long-term complications, including neuromuscular irritability, renal complications, extra-skeletal calcifications, and cognitive impairment. Postsurgical hypoparathyroidism accounts for 78 percent of cases, with other etiologies that include autoimmune disorders, familial disorders, and idiopathic causes.

Yorvipath is a prodrug of parathyroid hormone (PTH 1-34) administered once daily. Treatment should be initiated and monitored by physicians or qualified healthcare professionals experienced in the diagnosis and management of patients with hypoparathyroidism. It is in development for adults with hypoparathyroidism in the United States, Japan, and other countries. Ascendis plans its first European Union launch of Yorvipath in January 2024 in Germany.

“Each patient living with chronic hypoparathyroidism faces serious health and quality of life concerns,” said Lorenz Hofbauer, professor of Medicine, Geriatrics, and Endocrinology at Technical University of Dresden. “To treat the underlying cause of disease, these patients need new treatment options that go beyond the limits and risks of conventional therapy, which today consists of oral calcium and active vitamin D.”