YORVIPATH® (Palopegteriparatide) Available in U.S. for Adult Hypoparathyroidism Treatment

On December 19, 2024, Ascendis Pharma A/S announced the commercial availability of YORVIPATH® in the United States. YORVIPATH, also known as palopegteriparatide and developed under the name TransCon PTH, is a prodrug of parathyroid hormone (PTH [1-34]) that offers a daily treatment option for adults with hypoparathyroidism. The medicine, the first of its kind to receive approval from the U.S. Food & Drug Administration (FDA) for this condition, is designed to deliver continuous exposure to active PTH over a 24-hour period.

Patty Keating, the Executive Director of the HypoPARAthyroidism Association, expressed excitement at the availability of YORVIPATH in the United States. She noted that patients involved in clinical trials have reported significant improvements in their lives, and the new treatment provides both patients and physicians with a novel approach to addressing hypoparathyroidism, a challenging hormone deficiency.

Jan Mikkelsen, President and CEO of Ascendis Pharma, emphasized the company's commitment to meeting the urgent medical needs of those living with hypoparathyroidism. By introducing YORVIPATH to the U.S. market, Ascendis aims to ensure patients have access to this innovative treatment. The company has established the YORVIPATH team within the Ascendis Signature Access Program® to assist patients throughout their treatment journey. This team includes specially trained nurses who offer comprehensive support programs, such as clinical education, assistance with prior authorization, training on injection procedures, and financial aid for eligible patients.

Hypoparathyroidism is a disorder that results from insufficient production of parathyroid hormone, which is crucial for maintaining calcium and phosphate balance in the body. This hormone acts directly on the bones and kidneys and indirectly on the intestines. The condition can lead to numerous severe and potentially life-threatening complications, including neuromuscular irritability, kidney problems, abnormal calcium deposits in tissues, and cognitive difficulties. Most cases (70-80%) are related to surgical procedures, with other cases stemming from autoimmune or idiopathic causes.

Ascendis Pharma is renowned for its innovative use of TransCon technology, which supports the company's goal of becoming a leading biopharmaceutical entity. The company is dedicated to developing therapies that significantly impact patients' lives, guided by its core principles of Patients, Science, and Passion. Ascendis Pharma is headquartered in Copenhagen, Denmark, and operates additional facilities across Europe and the United States.