FDA Pushes Review Date For Ascendis Pharma's Hormone Disorder Candidate By Three Months
FDA Pushes Review Date For Ascendis Pharma's Hormone Disorder Candidate By Three Months
Tuesday, Ascendis Pharma A/S (NASDAQ:ASND) announced that the FDA extended the review date for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism.
週二，Ascendis Pharma A/S（納斯達克股票代碼：ASND）宣佈，美國食品藥品管理局延長了對成人甲狀旁腺功能減退的TransCon PTH（palopegteriparatide）的審查日期。
Hypoparathyroidism is an uncommon condition in which the body produces abnormally low levels of parathyroid hormone (PTH).
甲狀旁腺功能減退是一種罕見的疾病，人體產生的甲狀旁腺激素（PTH）水平異常低。
The low production of PTH in hypoparathyroidism leads to abnormally low calcium levels in the blood and an increase of phosphorus in the blood.
甲狀旁腺功能減退症中 PTH 的低產量會導致血液中鈣水平異常低和血液中磷的增加。
The agency said the information Ascendis Pharma submitted in response to the FDA's ongoing review of the New Drug Application (NDA) for TransCon PTH constituted a major amendment to the NDA.
該機構表示，Ascendis Pharma爲回應美國食品藥品管理局正在進行的對TransCon PTH新藥申請（NDA）的審查而提交的信息構成了對保密協議的重大修正。
Accordingly, the FDA has extended the PDUFA target action date by three months to August 14, 2024, from May 14 to provide time for a full submission review.
因此，美國食品和藥物管理局已將PDUFA的目標行動日期從5月14日延長了三個月，至2024年8月14日，以便有時間進行全面的提交審查。
"We have responded to all requests received to date from FDA and will work with the agency as they continue their review of our NDA," said Jan Mikkelsen, Ascendis Pharma's President and CEO.
騰飛製藥總裁兼首席執行官揚·米克爾森表示：“我們已經回應了迄今爲止從美國食品藥品管理局收到的所有請求，並將與該機構合作，繼續審查我們的保密協議。”
Also Read: Ascendis Pharma's Growth Hormone Deficiency Candidate Outperforms in Phase 3 Trial.
另請閱讀： Ascendis Pharma的生長激素缺乏症候選藥物在3期試驗中表現優異。
The company said adults with hypoparathyroidism in the United States, who are receiving TransCon PTH in clinical trials and Expanded Access Program will continue to receive their medication, and the EAP remains open for enrollment for eligible patients.
該公司表示，在美國患有甲狀旁腺功能減退的成年人如果正在臨床試驗和擴大准入計劃中接受TransCon PTH，他們將繼續接受藥物治療，EAP仍對符合條件的患者開放。
Last year, the FDA notified deficiencies in Ascendis Pharma's marketing application for TransCon PTH (palopegteriparatide) in hypoparathyroidism.
去年，美國食品藥品管理局通報了Ascendis Pharma針對甲狀旁腺功能減退的TransCon PTH（palopegteriparatide）的上市申請存在缺陷。
Monday, the company announced 2-year results from a post-hoc analysis of the Phase 3 PaTHway Trial demonstrating significant and sustained improvements in renal function in adults with chronic hypoparathyroidism treated with TransCon PTH.
週一，該公司公佈了對3期PathWay試驗的2年事後分析結果，該結果顯示，接受TransCon PTH治療的慢性甲狀旁腺功能減退的成年人的腎功能明顯持續改善。
The treatment has already been approved in Europe and Britain and is marketed under Yorvipath. The company reported first-quarter sales of 1.5 million euros for the first two months since its launch.
該療法已在歐洲和英國獲得批准，並由Yorvipath上市。該公司報告稱，自成立以來的前兩個月，第一季度銷售額爲150萬歐元。
Price Action: ASND shares were up 0.94% at $125.99 at the last check on Wednesday.
價格走勢：在週三的最後一次支票中，ASND股價上漲0.94％，至125.99美元。
譯文內容由第三人軟體翻譯。