Ascendis Pharma's hypoparathyroidism drug scores European approval after refiling in the US
Ascendis Pharma’s Yorvipath was approved in Europe on Monday, days after the company refiled its application for the hypoparathyroidism hopeful in the US.
Yorvipath, also known as palopegteriparatide, is a prodrug of the parathyroid hormone, which is made by the parathyroid glands and controls levels of calcium in the blood.
The FDA rejected the drug earlier this year after regulators raised concerns about the “manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination,” according to Ascendis. The company said at the time that the agency “did not express concern” about the clinical data, and no new preclinical or Phase III studies were requested. Ascendis refiled its new drug application in the US last week after getting some clarity at an FDA meeting in August.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.