The Food and Drug Administration on Monday approved a hormonal replacement drug from Ascendis Pharma for a rare endocrine condition known as hypoparathyroidism.

美国食品和药物管理局周一批准了Ascendis Pharma的一种激素替代药物，用于治疗一种罕见的内分泌疾病，即甲状旁腺功能减退症。

The drug, which Ascendis will sell as Yorvipath, is a prodrug formulation of the parathyroid hormone, levels of which are insufficiently low in the 70,000 to 90,000 people in the U.S. estimated to have the condition,

Ascendis将以Yorvipath的名义销售该药物，该药物是甲状旁腺激素的前药制剂，在美国估计有7万至9万人患有甲状旁腺激素水平不足，

Ascendis is still working on ramping up its manufacturing and plans to make supply of Yorvipath available in the first quarter of next year. Shares in Ascendis rose by as much as 10% Monday morning on the news.

Ascendis仍在努力扩大其制造规模，并计划在明年第一季度提供Yorvipath的供应。周一早上消息传出后，Ascendis的股价上涨了10%。

A little over one year ago, Ascendis was hit with a complete response letter from the FDA, which denied its drug an approval over the company’s “manufacturing control strategy for variability of delivered dose.”

一年多前，Ascendis收到了FDA的完整回复信，该回复信否认其药物获得了该公司“针对递送剂量变异性的制造控制策略”的批准

Ascendis resubmitted its application in November with an updated strategy, but then saw the agency delay its review by three months to review additional information submitted by the company.

Ascendis于11月重新提交了申请，并更新了战略，但随后该机构将审查推迟了三个月，以审查该公司提交的其他信息。

Even now with an approval in hand, Ascendis has moved back its expectations for a market launch from the third quarter this year to the first quarter of next year. (However, it does plan to ask the FDA for an OK to commercialize some of its existing manufactured products, which would allow it to introduce Yorvipath in the fourth quarter.).

即便现在获得批准，Ascendis也将其对市场推出的预期从今年第三季度推迟到明年第一季度。（然而，它确实计划要求FDA批准其现有的一些制造产品商业化，这将使其能够在第四季度推出Yorvipath。）。

Manufacturing hiccups aside, the FDA granted Yorvipath a label that analysts described as “clean,” “broad” and containing “no surprises.” Specifically, the agency didn’t require a black box warning for the risk of osteosarcoma, which it did for two other drugs, Natpara and Forteo, that are also parathyroid hormone analogs..

撇开制造业的打嗝不谈，美国食品药品管理局（FDA）给Yorvipath贴上了一个标签，分析人士称该标签“干净”，“宽泛”，并且“不令人惊讶”。具体来说，该机构不需要骨肉瘤风险的黑盒警告，就像它对另外两种同样是甲状旁腺激素类似物的药物Natpara和Forteo所做的那样。。

Natpara, made by Takeda, has been the only prescription medicine available in the U.S. for hypoparathyroidism. But the company will stop making it available by the end of this year due to unresolved manufacturing issues.

Takeda生产的Natpara是美国唯一一种治疗甲状旁腺功能减退症的处方药。但由于制造问题尚未解决，该公司将在今年年底停止提供。

The condition can cause low calcium levels and lead to a range of complications. Testing of Yorvipath, which is built around Ascendis “Transcon” drug delivery technology, showed treatment restored normal calcium levels. The drug was previously approved in Europe and the U.K.

这种情况会导致低钙水平并导致一系列并发症。围绕Ascendis“Transcon”药物输送技术构建的Yorvipath测试表明，治疗恢复了正常的钙水平。该药物先前已在欧洲和英国获得批准。

Yorvipath is Ascendis’ second approved drug in the U.S.; the company also makes Skytrofa for pediatric growth hormone deficiency. The company told analysts that it hasn’t yet decided on the U.S. pricing for Yorvipath, which it sells for around $100,000 per year in Europe.

Yorvipath是Ascendis在美国的第二种批准药物。；该公司还生产Skytrofa治疗小儿生长激素缺乏症。该公司告诉分析师，尚未决定Yorvipath在美国的定价，该公司在欧洲的年售价约为10万美元。