FDA approves Ascendis drug for rare endocrine condition
A hormone replacement therapy from Ascendis Pharma has been licensed by the Food and Drug Administration to treat hypoparathyroidism, an uncommon endocrine disorder. The medication, which Ascendis will market under the brand name Yorvipath, is a prodrug formulation of parathyroid hormone, the levels of which are thought to be insufficiently low in the 70,000–90,000 Americans who are thought to have the condition. While Ascendis continues to work on increasing production, Yorvipath should be available in the first quarter of 2019.
The FDA sent Ascendis a comprehensive response letter a little over a year ago, rejecting the company's request for medication clearance due to their "manufacturing control strategy for variability of delivered dose." When Ascendis resubmitted its application in November with an amended plan, the government postponed its evaluation for three months to examine further data that the firm had provided. Ascendis has already rescheduled its anticipated market debut from the third quarter of this year to the first quarter of next year, even with FDA approval in hand. (It does, however, intend to get FDA approval to market a few of its currently produced goods, enabling it to launch Yorvipath in the fourth quarter.)
