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Ascendis Pharma have announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for YORVIPATH (palopegteriparatide; developed as TransCon PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, and has also granted YORVIPATH orphan drug status. YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily.
“With today’s MHRA approval of YORVIPATH, we are expanding our global geographic reach to meet the needs of adults with chronic hypoparathyroidism in Great Britain,” said Camilla Harder Hartvig, Executive Vice President and Chief Commercial Officer at Ascendis Pharma.
MHRA approval of YORVIPATH is based on the same dossier submitted with Ascendis Pharma’s Marketing Authorisation Application to the European Medicines Agency, which led to European Commission authorisation of YORVIPATH in the European Union in November 2023. Orphan status provides 10 years of market exclusivity in Great Britain with respect to similar medicinal products in the approved orphan indication of chronic adult hypoparathyroidism. TransCon PTH is also in development for the treatment of adults with chronic hypoparathyroidism in the United States, Japan, and other countries.