European Commission approves 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.”