Dive Brief:

概要：

Kalvista Therapeutics said Friday that the Food and Drug Administration will

卡尔维斯塔制药公司周五表示，食品和药物管理局将

miss a deadline to approve its experimental drug for hereditary angioedema

错过批准其遗传性血管性水肿实验药物的最后期限

because of “resource constraints” at the agency.

由于该机构的“资源限制”。

According to Kalvista, the FDA notified the company on Thursday that it will be unable to issue a decision on the therapy, called sebetralstat, by June 17 because of a “heavy workload and limited resources.” The regulator expects to deliver a verdict within about four weeks, Kalvista said.

据 Kalvista 称，FDA 周四通知该公司，由于“工作量繁重且资源有限”，将无法在 6 月 17 日之前对名为 sebetralstat 的疗法作出决定。Kalvista 表示，监管机构预计将在大约四周内给出裁决。

Kalvista claimed the delay isn’t related to any issues with its clinical results and noted that the FDA hasn’t asked the company for any additional data. The only remaining item under FDA review is finalizing the drug’s prescribing information, the company said.

卡拉维斯塔声称，此次延迟与临床结果无关，并指出FDA并未要求该公司提供任何额外数据。公司表示，FDA审查的唯一剩余事项是最终确定药物的处方信息。

Dive Insight:

深入洞察：

Drug reviews typically follow a predictable timeline. Once an approval application is accepted, the FDA usually decides within six or 10 months whether to clear a new medicine.

药物审查通常遵循可预测的时间表。一旦批准申请被接受，FDA通常会在六到十个月内决定是否批准新药。

The Trump administration’s dramatic downsizing of the FDA earlier this year, however, has sparked concerns about the agency’s ability to meet that goal. Though drug reviewers were supposed to be spared from agency layoffs, many of their supporting employees and teams have been cut.

然而，特朗普政府今年早些时候对FDA的大幅裁员引发了人们对该机构实现这一目标能力的担忧。尽管药物审查人员本应免于被裁，但他们的许多支持员工和团队已被削减。

FDA commissioner Martin Makary has been adamant that drug evaluations aren’t being compromised. “The trains are running on time,” he testified at a

FDA专员马丁·马卡里一直坚称药物评估并未受到损害。他在一次作证时说：“火车正点运行。”

Senate hearing

参议院听证会

last month. Many deadlines have been met so far and, in some cases, drugs have been cleared ahead of schedule.

上个月。许多最后期限已经满足，而且在一些情况下，药品已经提前清理完毕。

Still, a few companies —

不过，还是有一些公司——

Novavax

诺瓦瓦克斯

,

，

GSK

葛兰素史克

,

，

Stealth Biotherapeutics

隐形生物治疗公司

and

和

Vanda Pharmaceuticals

万达制药公司

— have reported unexpected delays in agency decisionmaking. Kalvista is now part of that group but, unlike the others, said it was specifically told that limited agency resources were the cause. The company had responded to all of the FDA’s requests “in a timely manner,” it said in its statement.

—— 报告了机构决策中的意外延迟。Kalvista现在也是其中一员，但不同于其他公司，该公司表示其被明确告知原因是机构资源有限。公司在声明中表示，已“及时”回应了FDA的所有要求。

While other deadlines have been missed, “this situation with [Kalvista] is the first instance that we are aware of that is directly related to resource constraints at the FDA,” wrote Leerink Partners analyst Joseph Schwartz.

虽然其他一些截止日期也被错过了，但“与[Kalvista]相关的这种情况是我们所知的第一个直接与FDA资源限制相关的事例，”Leerink Partners分析师Joseph Schwartz写道。

After connecting with Kalvista management, Schwartz noted that the FDA division reviewing sebetralstat is the same unit that missed a deadline for GSK’s lung disease drug Nucala earlier this year. That division has also simultaneously been reviewing a different hereditary angioedema drug from CSL that has the same June 17 decision deadline..

在与 Kalvista 管理层沟通后，施瓦茨指出，负责审核塞贝曲斯坦的 FDA 部门，与今年早些时候错过 GSK 肺病药物 Nucala 审批期限的是同一个部门。该部门同时还一直在审核来自 CSL 的另一种遗传性血管水肿药物，其决定期限同样是 6 月 17 日。

“Thus, it appears as if this is a division that has been under a heavy workload recently, which has caused some goal dates to be missed,” Schwartz added, adding that his team is “confident in the eventual approval” of sebetralstat.

“因此，似乎这个部门最近工作量很大，导致一些目标日期未能达成，”施瓦茨补充道，他的团队对 sebetralstat 的“最终获批充满信心”。

Kalvista’s drug is meant to be an oral alternative to the injectable medicines typically used to treat the hallmark swelling attacks afflicting people with hereditary angioedema. In testing,

卡尔维斯塔的药物旨在成为通常用于治疗遗传性血管性水肿患者标志性肿胀发作的注射药物的口服替代品。在测试中，

sebetralstat proved it could provide comparable symptom relief to those therapies

塞贝曲普坦证明它可以提供与那些疗法相似的症状缓解效果。

, yet the company has faced persistent questions about the need for its medicine.

，然而该公司一直面临对其药品需求的持续质疑。

Analysts at the investment bank Stifel have estimated that Kalvista’s drug will generate $600 million in annual U.S. sales at its peak.

投资银行Stifel的分析师估计，Kalvista的药物在其销售高峰期将实现每年6亿美元的美国销售额。