– PDUFA goal date is May 14, 2024
COPENHAGEN, Denmark I December 11, 2023 I Ascendis Pharma A/S (Nasdaq: ASND) today announced 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.
“We are pleased that the FDA can continue its review of TransCon PTH and look forward to working with the agency during its review,” said Jan Mikkelsen, President and CEO at Ascendis Pharma. “Given the significant unmet needs of the hypoparathyroidism community, we remain committed to making TransCon PTH available for U.S. patients as rapidly as possible.”
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Germany (Heidelberg and Munich) and the United States (Palo Alto and Redwood City, California, and Princeton, New Jersey). Please visit ascendispharma.com to learn more.
SOURCE: Ascendis Pharma
Post Views: 218
– PDUFA goal date is May 14, 2024
COPENHAGEN, Denmark I December 11, 2023 I Ascendis Pharma A/S (Nasdaq: ASND) today announced 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.
“We are pleased that the FDA can continue its review of TransCon PTH and look forward to working with the agency during its review,” said Jan Mikkelsen, President and CEO at Ascendis Pharma. “Given the significant unmet needs of the hypoparathyroidism community, we remain committed to making TransCon PTH available for U.S. patients as rapidly as possible.”
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Germany (Heidelberg and Munich) and the United States (Palo Alto and Redwood City, California, and Princeton, New Jersey). Please visit ascendispharma.com to learn more.
SOURCE: Ascendis Pharma
Post Views: 218
