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Yorvipath Gains European Commission Approval for Chronic Hypoparathyroidism

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Ascendis Pharma’s Yorvipath (palopegteriparatide) has received approval from the European Commission (EC) for the treatment of chronic hypoparathyroidism in adults. This approval comes after the drug faced a rejection from the US Food and Drug Administration (FDA) earlier this year. Yorvipath, a prodrug of parathyroid hormone (PTH 1-34), will be launched in Germany in January 2024. The drug addresses the low levels of endogenous parathyroid hormone in patients with hypoparathyroidism.

The decision by the EC follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2023. This marks a divergence from the FDA’s decision, which rejected the drug, then known as TransCon PTH, for hypoparathyroidism, citing manufacturing control concerns rather than issues with clinical data.

Chronic Hypoparathyroidism

Promising One-Year Data from Phase III Trial Spark Hope for Chronic Hypoparathyroidism Patients

In June, Ascendis reported favorable one-year data from the Phase III PaTHway trial (NCT04701203) of Yorvipath. The trial results indicated that a significant percentage of patients achieved independence from conventional therapy, eliminating the need for active vitamin D supplements commonly used to correct abnormal calcium levels associated with the disease. At week 52, 81% of participants had normal serum calcium levels.

Professor Lorenz C Hofbauer, an expert in Medicine, Geriatrics, and Endocrinology at the Technical University of Dresden, emphasized the need for new treatment options beyond conventional therapies for chronic hypoparathyroidism, which typically involves oral calcium and active vitamin D.

Ascendis Pharma CEO Jan Mikkelsen expressed a commitment to making Yorvipath widely accessible, recognizing the urgent demand from patients and healthcare providers for new treatment choices.


Resource: Pharmaceutical Technology, November 21, 2023

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