– YORVIPATH (developed as TransCon PTH) is a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism

– Ascendis plans its first EU launch of YORVIPATH in Germany in January 2024

COPENHAGEN, Denmark I November 20, 2023 I Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for YORVIPATH® (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily. Ascendis plans its first European Union (EU) launch of YORVIPATH in January 2024 in Germany.

“Each patient living with chronic hypoparathyroidism faces serious health and quality of life concerns,” said Professor Lorenz C. Hofbauer, Professor of Medicine, Geriatrics, and Endocrinology, 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.”

The EC approval follows the positive opinion adopted on September 14, 2023 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of YORVIPATH.

“By focusing on patient need and using science to drive our decisions, we have brought YORVIPATH – our second approved TransCon product – from concept through EU marketing authorization in only eight years and we are preparing to launch it in Germany this coming January,” said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. “Knowing the urgent need that many patients and physicians have expressed for new treatment options, we will continue our work to make YORVIPATH widely available.”

TransCon PTH will be marketed in the EU as YORVIPATH, a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. Treatment should be initiated and monitored by physicians or qualified healthcare professionals experienced in the diagnosis and management of patients with hypoparathyroidism. TransCon PTH is in development for adults with hypoparathyroidism in the United States, Japan, and other countries.

About 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 >6 months following surgery per the 2016 Endocrine Society Guidelines, 2019 Canadian and International Consensus Statement, and 2022 European Society of Endocrinology Consensus Statement. 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 the majority of cases (78%), with other etiologies that include autoimmune disorders, familial disorders, and idiopathic causes.

About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Germany (Heidelberg and Munich) and the United States (Palo Alto and Redwood City, California, and Princeton, New Jersey). Please visit ascendispharma.com to learn more.

SOURCE: Ascendis Pharma