Ascendis Pharma A/S has announced that the Medicines & Healthcare Products Regulatory Agency in the United Kingdom has given the green light to YORVIPATH®. This marks a significant step forward as it's now authorized for treating adults with chronic hypoparathyroidism in Great Britain, with YORVIPATH also receiving orphan drug status.

Camilla Harder Harvig, Executive Vice President and Chief Commercial Officer at Ascendis Pharma, emphasized the importance of this approval, saying, “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 MHRA's decision is based on the same dossier submitted for the European Medicines Agency, which led to the European Commission’s approval of YORVIPATH in the European Union in November 2023. YORVIPATH now enjoys 10 years of market exclusivity in Great Britain for the treatment of chronic adult hypoparathyroidism. Ascendis Pharma is also developing TransCon PTH for the same indication in the United States, Japan, and other countries.

Hypoparathyroidism, an endocrine disorder characterized by insufficient levels of PTH, poses significant health risks due to its effects on calcium and phosphate balance in the body. It is considered chronic if it persists for more than six months following surgery, as defined by various medical guidelines. Individuals with hypoparathyroidism may face severe complications, including neuromuscular irritability, renal issues, extra-skeletal calcifications, and cognitive impairment. While post-surgical hypoparathyroidism is the most common cause, other factors such as autoimmune, genetic, and idiopathic origins contribute to this condition.

 

Source: globenewswire.com

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