MHRA approves Ascendis Pharma’s Yorvipath for hypoparathyroidism treatment
Ascendis Pharma has announced that the UK’s Medicines and 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 for the treatment of adult patients with chronic hypoparathyroidism.
The MHRA has also granted the drug orphan drug status.
This MHRA approval of Yorvipath is based on the same dossier submitted with Ascendis Pharma’s marketing authorisation application submitted to the European Medicines Agency (EMA), which previously led to European Commission (EC) approval of Yorvipath in the EU as of November 2023.
‘Hypoparathyroidism is an endocrine disease caused by insufficient levels of PTH, the primary regulator of calcium and phosphate balance in the body, acting directly on bone and kidneys and indirectly on the intestine. Hy poparathyroidism is considered chronic if it persists >6 months following surgery’, according to the company’s press release.
Camilla Harder Harvig, executive vice president and chief commercial officer at Ascendis Pharma, commented: “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.”
The drug is also in development for the treatment of adult patients with chronic hypoparathyroidism in the US and Japan, as well as various other countries.