A year after rejecting it, the FDA has now approved Ascendis Pharma’s once-daily injectable YORVIPATH for hypoparathyroidism treatment. Ascendis Pharma’s YORVIPATH (palopegteriparatide), formerly called TransCon PTH, has been approved for the treatment of adults with hypoparathyroidism. This rare condition, characterized by a lack of parathyroid hormone (PTH), impacts approximately 270K individuals in the seven major countries [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan], as per DelveInsight.
The company initially planned to launch the drug 15 months ago, but the FDA unexpectedly rejected it with a complete respons...