Ascendis Pharma Says FDA Accepts Resubmitted NDA For TransCon PTH In Adults With Hypoparathyroidism
(RTTNews) - Ascendis Pharma A/S (ASND) announced Monday that the U.S. Food & Drug Administration (FDA) has accepted for review the Company's resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism.
The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024.
In the United States, TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.
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Ascendis Pharma Says UK Approves YORVIPATH For Treatment Of Adults With Chronic Hypoparathyroidism
Danish pharmaceutical company Ascendis Pharma A/S (ASND) announced that the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH (palopegteriparatide; developed as TransCon PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism
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