11:33 AM EDT, 04/24/2024 (MT Newswires) -- Ascendis Pharma ( ASND ) said Wednesday that the UK's Medicines and Healthcare Products Regulatory Agency has granted marketing authorization for Yorvipath as a parathyroid hormone, or PTH, replacement therapy to treat adults with chronic hypoparathyroidism.
The UK regulator also granted orphan drug status to Yorvipath, or palopegteriparatide, providing 10 years of market exclusivity in Great Britain with respect to similar medicinal products in the approved orphan indication of chronic adult hypoparathyroidism, the company said.
Hypoparathyroidism is an endocrine disease caused by insufficient levels of PTH, which regulates calcium and phosphate balance in the body, according to Ascendis.
The company added that the MHRA authorization was based on the same data submitted with its marketing application to the European Medicines Agency, which led to the therapy's authorization in the European Union in November.
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