FDA Approves Yorvipath for Hypoparathyroidism
Ascendis Pharma's Second TransCon Product Receives Green Light
Yorvipath is the only approved treatment for hypoparathyroidism in the United States.
Ascendis Pharma A/S announced on Monday that the U.S. Food and Drug Administration (FDA) has approved Yorvipath (teriparatide injection) for the treatment of hypoparathyroidism, a rare endocrine disease caused by insufficient parathyroid hormone (PTH). Hypoparathyroidism can lead to a range of symptoms, including muscle weakness, fatigue, muscle cramps, seizures, and cataracts.
Yorvipath is a recombinant human parathyroid hormone (rhPTH) that is administered subcutaneously. It is the first and only FDA-approved treatment specifically for hypoparathyroidism in the United States. Prior to the approval of Yorvipath, patients with hypoparathyroidism were treated with a variety of medications, including calcium and vitamin D supplements, which can have significant side effects and are not always effective.
The FDA's approval of Yorvipath is based on the results of two Phase 3 clinical trials that showed that Yorvipath was safe and effective in treating hypoparathyroidism. In one trial, Yorvipath significantly reduced the number of hospitalizations and emergency room visits, and improved quality of life in patients with hypoparathyroidism.
"The FDA's approval of Yorvipath is a major milestone for Ascendis Pharma and for the patients with hypoparathyroidism who have been waiting for a safe and effective treatment," said Jan Mikkelsen, CEO of Ascendis Pharma. "We are committed to developing and delivering innovative therapies that address the needs of patients with rare diseases."
Yorvipath is expected to be available in the United States in the coming months. Ascendis Pharma has not yet announced the price of Yorvipath.
The FDA's approval of Yorvipath is a significant victory for Ascendis Pharma and for patients with hypoparathyroidism. This approval underscores Ascendis Pharma's commitment to developing and delivering innovative therapies that address the needs of patients with rare diseases.
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