Yorvipath for adult patients now available in Germany and Austria
Formerly called TransCon PTH, the therapy is under approval review in US, UK
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, the second marketed product developed using Ascendis’ TransCon technology platform, currently is being considered for approval in the U.K. and U.S.
“We are pleased to initiate the launch of YORVIPATH to address the needs expressed within the hypoparathyroidism community for a new PTH-based treatment option,” Jan Mikkelsen, president and CEO of Ascendis, said in a company press release.
Yorvipath works to treat hyoparathyroidism by helping to control calcium levels
Hypoparathyroidism is caused by abnormally low levels of parathyroid hormone (PTH). This hormone normally helps to regulate levels of calcium and other nutrients, and standard treatment involves supplements of calcium and vitamin D, which helps the body absorb calcium.
Yorvipath contains a precursor to PTH that is converted into the active hormone once inside the body. Given by subcutaneous (under-the-skin) injection once daily, the therapy aims to help control calcium levels while minimizing the need for supplements.
Its approval in Europe was supported by findings from a Phase 3 clinical trial called PaTHway (NCT04701203) and a Phase 2 study called PaTH Forward (NCT04009291). Data from both trials indicated that treatment with Yorvipath could help to normalize calcium levels and lower dependence on supplements. Most treated PaTHway patients attained normal calcium levels after a year of the therapy’s use.
Yorvipath is under review for potential approval in the U.K., where a decision is expected in the next month or two, and in the U.S., where a decision is expected by mid-May. The medication also is in development in Japan and China, the company reported.
A separate treatment by Ascendis with regulatory approval is for children with growth failure due to inadequate endogenous growth hormone, and a broader company goal is to develop therapies for several hormone-related disorders over the next few years.
“With an increasingly broad commercial infrastructure in place, we are well positioned to accomplish this by expanding the availability of YORVIPATH and our other approved products to meet the needs of physicians and patients around the world,” Mikkelsen said.