FDA approves palopegteriparatide as first treatment for hypoparathyroidism in adults

The U.S. Food and Drug Administration (FDA) has approved palopegteriparatide (Yorvipath), as the first and only treatment specifically designed for adults with hypoparathyroidism.

This rare endocrine disorder, characterized by insufficient levels of parathyroid hormone, can lead to serious complications, including low calcium levels, muscle cramps, and neurological issues.

Approval is based on results from 2 major clinical trials: the global Phase 2 PaTH Forward trial and the Phase 3 PaTHway trial.

“FDA approval of our second TransCon product, Yorvipath, reflects our values and dedication to following the science to help patients, as well as our unwavering commitment these past years to addressing the significant unmet medical needs of the hypoparathyroidism community in the United States,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer in a press release. “We are deeply grateful to patients, clinicians, and advocates for their many contributions to this important milestone.”

Read the full press release here.