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…
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…
Slightly less than 20% of people who had their thyroid gland removed had hypoparathyroidism a year after the surgery, according to a 20-year study in Denmark. An increase in mortality risk was only found when the the surgery was due to cancer, but mortality was unaffected in benign cases.
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 (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,…
People with higher body fat — as measured by body mass index, or BMI — have a lower risk of developing hypoparathyroidism following total thyroidectomy, a surgery that completely removes the thyroid glands, a new study reports. Besides body fat, levels of parathyroid hormone (PTH) before surgery and a…
The European Commission has approved palopegteriparatide, also known as TransCon PTH, to treat adults with chronic hypoparathyroidism. Ascendis Pharma, the therapy’s developer, will market it in the European Union under the brand name Yorvipath, and expects the therapy’s commercial launch to begin in Germany next month. An…
Use of Natpara (recombinant human parathyroid hormone) during early pregnancy and breastfeeding did not lead to significant adverse events for a woman with hypoparathyroidism or her two children, according to a recent case report from the U.S. The therapy’s safe use during pregnancy or while breastfeeding has not…
The experimental therapy TransCon PTH was effective at controlling hypoparathyroidism caused by neck surgery for most patients in the PaTHway clinical trial, according to data presented at the American Thyroid Association (ATA) annual meeting by its developer Ascendis Pharma. “We are pleased to share with thyroid surgeons…
People with hypoparathyroidism experience worse quality of life, with women showing a higher burden of disease than men, according to a recent survey in Germany. In addition, patients who’ve had the disease longer report a lower burden of their symptoms. “Investigations on potential coping strategies might give an explanation…
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