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FDA approves Ascendis Pharma's hormone disorder therapy
A signage outside of the Food and Drug Administration headquarters in White Oak, Maryland, US. Yorvipath will become the only approved treatment for the hypoparathyroidism condition in the United States. — Reuters File
Ascendis Pharma's said on Monday the US Food & Drug Administration had approved its therapy to treat adult patients with a hormone disorder.
Ascendis, which had been trying for years to bring the treatment to market, anticipates initial supply of the once-daily therapy will be available in the first quarter of 2025.
The Danish drugmaker's treatment, Yorvipath, will become the only approved treatment for the condition in the United States after rival Takeda stops manufacturing its injection, Natpara, at the end of this year.
Natpara was initially approved in 2015, but unresolved supply issues have resulted in discontinuation of the treatment.
The condition, hypoparathyroidism, is a rare endocrine disease caused by low levels of parathyroid hormone that impact multiple organs and affects an estimated 70,000 to 90,000 people in the United States, according to the company. Low production of parathyroid hormone in hypoparathyroidism leads to abnormally low calcium levels in the blood and an increase of phosphorus.
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