The FDA has approved a new therapy to treat adult patients with hypoparathyroidism.
The once-daily treatment, Palopegteriparatide, is expected to be available in the first quarter of 2025.
This approval comes as Takeda plans to discontinue manufacturing its parathyroid hormone injection at the end of this year due to unresolved supply issues. Takeda's product was initially approved in 2015.
Palopegteriparatide will become the only FDA-approved treatment for hypoparathyroidism in the U.S., a rare endocrine disorder affecting an estimated 70,000 to 90,000 people in the country
The new treatment aims to address the abnormally low calcium levels and increased phosphorus levels characteristic of hypoparathyroidism.