Ascendis Pharma A/S (Nasdaq: ASND) has declared the launch of YORVIPATH® (palopegteriparatide, developed as TransCon PTH) in Germany and Austria. YORVIPATH is a parathyroid hormone (PTH) replacement therapy designed for adults dealing with chronic hypoparathyroidism. This marks the commercial introduction of Ascendis Pharma’s second product utilizing the TransCon technology platform.

Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer, expressed satisfaction with the initiation of YORVIPATH's launch, emphasizing its role in meeting the unmet medical needs of the hypoparathyroidism community. This launch represents a significant milestone in Ascendis Pharma's strategic plan, aiming to achieve regulatory approvals for three Endocrinology Rare Disease products by 2025 under Vision 3x3 and attain blockbuster status for each by 2030 under Vision 2030.

YORVIPATH (palopegteriparatide, developed as TransCon PTH) is a once-daily administered prodrug of parathyroid hormone (PTH 1-34), designed to maintain physiological PTH levels throughout the 24-hour dosing period. The European Commission granted marketing authorization for YORVIPATH in November 2023, targeting adults with chronic hypoparathyroidism. The Medicines & Healthcare Products Regulatory Agency (MHRA) is expected to decide on YORVIPATH in the United Kingdom during the first quarter of 2024. In the United States, the U.S. Food & Drug Administration (FDA) has set a PDUFA date of May 14, 2024, for the review of Ascendis Pharma’s New Drug Application for TransCon PTH in adults with chronic hypoparathyroidism.

Additionally, TransCon PTH is under development in Japan through Teijin Ltd. and in China through VISEN Pharmaceuticals. Ascendis aims to expand the global reach of its Endocrinology Rare Disease portfolio, including YORVIPATH, through exclusive distribution agreements, with three agreements established to date.

Hypoparathyroidism, an endocrine disease caused by insufficient PTH levels, has severe short-term and long-term complications. YORVIPATH addresses this condition by providing a new treatment option, potentially improving the quality of life for individuals with chronic hypoparathyroidism.

 

Source: globenewswire.com

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