United States – Danish drugmaker Ascendis Pharma said in a statement that the US Food & Drugs Administration had green-lighted its therapy for adult patients with hormone disorders, and its shares rose by over 10 percent in the premarket trade, as reported by Reuters.
Only Approved Treatment
Ascendis’s Yorvipath will hence be the only approved treatment for hypoparathyroidism in the United States, as Takeda (4502. T) terminated its injection known as Natpara in the current year due to supply concerns.
Approval for Yorvipath comes after a couple of hiccups: a failed FDA review in May and a rejection of approval last year on issues related to manufacturing controls of the drug and device combination.
In the middle and late phases, most of the patients treated with Yorvipath did not require daily vitamin D and calcium supplements—the treatments considered to be standard for hypoparathyroidism today.
It is an endocrine disease characterized by the hormonal deficiency of parathyroid and it occurs in the organs, and it is estimated to affect about 70,000 to 90,000 people in the United States as posted by the company.
Hypoparathyroidism affects the production of parathyroid hormone, which causes the calcium level in the blood to be below normal, and phosphorus rises.
Ascendis envisages that the initial supply of the once-daily will be ready in first quarter of 2025 while the firm expects to unveil the annual price of the therapy in the following week.
The Evercore ISI analyst Gavin Clark-Gartner has previously forecasted that the peak sale could be around $2.5 billion on an adjusted basis and is projecting the therapy to have an approximate market share of about 12.5% in the United States, as reported by Reuters.
Ascendis also intends to seek FDA permission to market other manufactured products for other markets, which, if granted, may be available in the United States in the last quarter of 2024.