Ascendis Pharma is seeking approval of its treatment candidate TransCon PTH for adults with hypoparathyroidism in the European Union, the company has announced. The request, submitted as a marketing authorization application (MAA) to the European Medicines Agency (EMA), follows a similar application submitted in September to the U.S.
News
Most experts report similar practices for how they monitor blood and urine tests in people with chronic hypoparathyroidism, but monitoring practices for disease complications like kidney or bone problems are more variable, a new study reports. “While [blood] and urine measurements are completed consistent with published guidelines and consensus…
Less experienced surgeons and removing lymph nodes in the neck during thyroid surgery are the main risk factors of accidentally damaging the neighboring parathyroid glands, which can cause hypoparathyroidism, a large study in China showed. A surgeon’s inexperience and a more advanced thyroid tumor also increased the risk of…
People with hypoparathyroidism who are on replacement therapy with Natpara, a version of the parathyroid hormone (PTH), are about half as likely to develop chronic kidney disease than patients who don’t receive the therapy, a study found. The study, “The risk of chronic kidney disease development in…
Daily treatment with AZP-3601, Amolyt Pharma’s experimental therapy for hypoparathyroidism, safely and effectively normalizes calcium levels in people with the disease, according to data from the second group of patients in a proof-of-concept Phase 2a clinical trial. Most participants stopped calcium and vitamin D supplements, which is the…
A Phase 1 clinical trial evaluating the safety and pharmacological properties of MBX 2109 — MBX Biosciences’ investigational hormone replacement therapy for people with hypoparathyroidism — in healthy volunteers has moved to its second part. This portion, which will test multiple MBX 2109 doses, follows the successful completion…
Parathyroid hormone (PTH) replacement therapy is superior to conventional treatment at lowering blood phosphate levels and the need for calcium and vitamin D supplements in people with chronic hypoparathyroidism, according to a review of clinical trial data. It appeared to be associated with higher-than-normal calcium levels (hypercalcemia) and had…
Persistent hypoparathyroidism after complete removal of the thyroid gland is more common than previously thought, a study in Japan has found. These findings, based on health insurance claims, add to previous reports linking persistent hypoparathyroidism after the surgery (called a total thyroidectomy) with greater risk for renal insufficiency and…
Treatment with AZP-3601, Amolyt Pharma’s experimental therapy for hypoparathyroidism, safely brought calcium levels to within normal ranges in the first group of patients in a Phase 2 clinical trial, the company has announced. Most of the trial participants were able to discontinue standard treatment with calcium and vitamin…
Ascendis Pharma has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of its treatment candidate TransCon PTH for adults with hypoparathyroidism, the company announced. “Our data support that TransCon PTH, if approved, could become the first-in-class therapy to address the underlying cause of…
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