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.
周二，Ascendis Pharma A/S（纳斯达克股票代码：ASND）宣布，美国食品药品管理局延长了对成人甲状旁腺功能减退的TransCon PTH（palopegteriparatide）的审查日期。
Hypoparathyroidism is an uncommon condition in which the body produces abnormally low levels of parathyroid hormone (PTH).
甲状旁腺功能减退是一种罕见的疾病，人体产生的甲状旁腺激素（PTH）水平异常低。
The low production of PTH in hypoparathyroidism leads to abnormally low calcium levels in the blood and an increase of phosphorus in the blood.
甲状旁腺功能减退症中 PTH 的低产量会导致血液中钙水平异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.
该机构表示，Ascendis Pharma为回应美国食品药品管理局正在进行的对TransCon PTH新药申请（NDA）的审查而提交的信息构成了对保密协议的重大修正。
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，美国食品和药物管理局已将PDUFA的目标行动日期从5月14日延长了三个月，至2024年8月14日，以便有时间进行全面的提交审查。
"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.
腾飞制药总裁兼首席执行官扬·米克尔森表示：“我们已经回应了迄今为止从美国食品药品管理局收到的所有请求，并将与该机构合作，继续审查我们的保密协议。”
Also Read: Ascendis Pharma's Growth Hormone Deficiency Candidate Outperforms in Phase 3 Trial.
另请阅读： Ascendis Pharma的生长激素缺乏症候选药物在3期试验中表现优异。
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.
该公司表示，在美国患有甲状旁腺功能减退的成年人如果正在临床试验和扩大准入计划中接受TransCon PTH，他们将继续接受药物治疗，EAP仍对符合条件的患者开放。
Last year, the FDA notified deficiencies in Ascendis Pharma's marketing application for TransCon PTH (palopegteriparatide) in hypoparathyroidism.
去年，美国食品药品管理局通报了Ascendis Pharma针对甲状旁腺功能减退的TransCon PTH（palopegteriparatide）的上市申请存在缺陷。
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.
周一，该公司公布了对3期PathWay试验的2年事后分析结果，该结果显示，接受TransCon PTH治疗的慢性甲状旁腺功能减退的成年人的肾功能明显持续改善。
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.
该疗法已在欧洲和英国获得批准，并由Yorvipath上市。该公司报告称，自成立以来的前两个月，第一季度销售额为150万欧元。
Price Action: ASND shares were up 0.94% at $125.99 at the last check on Wednesday.
价格走势：在周三的最后一次支票中，ASND股价上涨0.94％，至125.99美元。