The European Commission (EC) has granted marketing authorisation for YORVIPATH (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.
YORVIPATH is Ascendis Pharma’s prodrug of parathyroid hormone (PTH 1-34), administered once daily. Ascendis plans its first 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 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 in September 2023 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of YORVIPATH.
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. Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma, said: “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.”