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Ascendis’s Yorvipath Approved By FDA For Hypoparathyroidism But US Launch Delayed

Yorvipath Will Fill Gap Left By Takeda’s Natpara

 
• By Jessica Merrill

The US launch of Yorvipath will be delayed until Q4 2024 or early 2025 due to manufacturing, though the drug is already available in some European countries. 

Ascendis' cleared the US regulatory hurdle for Yorvipath • Source: Shutterstock

Ascendis Pharma A/S announced the US Food and Drug Administration approval of Yorvipath (palopegteriparatide) on 12 August for the treatment of hypoparathyroidism, but a US launch will be delayed while the company ramps up new manufacturing supply. In the best-case scenario, Yorvipath could be available in the US in 2024, but the launch may not happen until the first quarter of 2025.

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