FX.co ★ Ascendis Pharma Says UK Approves YORVIPATH For Treatment Of Adults With Chronic Hypoparathyroidism

The Danish pharmaceutical firm, Ascendis Pharma A/S, recently announced that the United Kingdom's healthcare authority, the Medicines & Healthcare products Regulatory Agency (MHRA), has authorized the marketing of YORVIPATH (also known as palopegteriparatide or TransCon PTH) in Great Britain. This drug serves as a parathyroid hormone replacement therapy, specifically intended for adults suffering from chronic hypoparathyroidism.

In addition to granting YORVIPATH marketing authorization, the MHRA has also awarded it the 'orphan drug' status. It is essentially a prodrug of the parathyroid hormone and is to be administered once a day.

The MHRA's approval of YORVIPATH was based on the same extensive set of documents that Ascendis Pharma had originally submitted to the European Medicines Agency for their Marketing Authorization Application. This subsequently led to the European Commission green-lighting YORVIPATH for use within the European Union in November 2023.

Significantly, the 'orphan status' secured by YORVIPATH guarantees ten years of market exclusivity in Great Britain, shielding it from competition with similar medicinal products in the approved 'orphan indication' for chronic adult hypoparathyroidism.

Besides the United Kingdom, TransCon PTH is also in the pipeline for treating adults living with chronic hypoparathyroidism in the United States, Japan, and numerous other countries.