News

FDA delays decision on TransCon PTH for hypoparathyroidism

The U.S. Food and Drug Administration (FDA) is delaying by three months its decision to approve Ascendis Pharma’s TransCon PTH (palopegteriparatide) as a hormone replacement therapy for adults with hypoparathyroidism. The FDA decided not to approve the investigational therapy in April 2023 over concerns about its manufacturing…

Eneboparatide, now in Phase 3 trial, placed on fast track by FDA

The U.S. Food and Drug Administration (FDA) has given fast track designation to eneboparatide, an experimental treatment for hypoparathyroidism that’s being investigated in a global Phase 3 clinical trial. This designation is intended to speed the development of therapies with the potential to address major unmet needs for serious…

Impaired kidney function is common in hypoparathyroidism

About one in five adults with hypoparathyroidism had impaired kidney function, according to a study based on real-life data. Ultrasounds also revealed calcium deposits in the kidneys of 10% of patients, which were predicted by low phosphate in the bloodstream and longer disease duration. The deposits didn’t appear to…

Yorvipath for adult patients now available in Germany and Austria

Yorvipath (palopegteriparatide), a treatment for hypoparathyroidism previously known as TransCon PTH, now is available to patients in Germany and Austria, according to the therapy’s developer, Ascendis Pharma. The announcement comes about two months after the European Commission approved Yorvipath to treat adults with chronic hypoparathyroidism. Yorvipath,…