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Ascendis Pharma Gets FDA Orphan Drug Designation for Hypoparathyroidism Treatment
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Ascendis Pharma Gets FDA Orphan Drug Designation for Hypoparathyroidism Treatment
Sep 12, 2024 3:09 AM

05:02 AM EDT, 09/12/2024 (MT Newswires) -- Ascendis Pharma ( ASND ) said late Wednesday the US Food & Drug Administration has granted orphan drug designation to Yorvipath, providing seven years of market exclusivity in the US for the treatment of hypoparathyroidism in adults.

Orphan drug designation provides drug developers with certain benefits and incentives, including the waiver of FDA user fees and tax credits for clinical research.

Hypoparathyroidism is an endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs, the company said.

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