EN
登录

Ligand用软体动物凝胶Zelsuvmi冲过美国食品药品监督管理局终点线

Ligand crosses FDA finish line with molluscum gel Zelsuvmi

Fierce Pharma 等信源发布 2024-01-08 08:26

可切换为仅中文


Less than six months after Ligand Pharmaceuticals swooped in to buy Novan’s assets following the latter company’s bankruptcy, the purchase has paid off with an FDA approval.

在Novan公司破产后,Ligand Pharmaceuticals突袭收购Novan资产不到六个月后,该收购获得了FDA的批准。

Late Friday, the FDA approved Ligand’s Zelsuvmi for the treatment of molluscum contagiosum in patients ages 1 and older. With the nod, Ligand’s topical gel becomes the first treatment for the highly contagious viral skin infection.

周五晚些时候,FDA批准了Ligand的Zelsuvmi用于治疗1岁及以上患者的传染性软体动物。随着nod的出现,配体的局部凝胶成为治疗高度传染性病毒性皮肤感染的第一种方法。

Zelsuvmi can be applied by patients, parents or others at home to treat a condition that's marked by lesions on a the skin.

Zelsuvmi可用于患者、父母或家中其他人治疗以皮肤病变为特征的疾病。

The FDA approved the drug based on a pair of phase 3 studies that enrolled a total of 1,598 patients. In the B-SIMPLE 2 and B-SIMPLE4 studies, the drug showed an ability to reduce the number of lesions compared with a vehicle gel, according to Ligand.

FDA根据一对共招募1598名患者的三期研究批准了该药物。根据配体,在B-SIMPLE 2和B-SIMPLE4研究中,与载体凝胶相比,该药物显示出减少病变数量的能力。

“For those of us in the primary care field, it is wonderful to have an effective option that can be used at home rather than taking a wait and watch approach,” pediatrician and study investigator Stephen Stripling, M.D., said in a statement.

“对于我们这些初级保健领域的人来说,拥有一个可以在家中使用的有效选择,而不是采取等待和观察的方法,这是非常棒的,”儿科医生兼研究调查员斯蒂芬·斯特普林(StephenStripling)在一份声明中说。

Before those approval-enabling results, another company, Novan, in early 2020 reported a pair of phase 3 failures that left the med’s future in doubt.

在这些获得批准的结果之前,另一家公司Novan在2020年初报告了两次3期失败,这让med的未来充满了疑问。

After that setback, Novan tried to press forward with its candidate but eventually had to file for bankruptcy. In July 2023, Ligand stepped in to buy out Novan's assets.

在那次挫折之后,诺万试图推动其候选人,但最终不得不申请破产。2023年7月,Ligand介入收购Novan的资产。

Related

相关

Ligand licenses prodrug tech to oral COVID-19 antiviral project

配体将前药技术许可给口服新型冠状病毒19抗病毒项目

About 6 million people are infected with molluscum each year in the U.S., according to Ligand, with most being children.

据Ligand称,美国每年约有600万人感染软体动物,其中大多数是儿童。

Ligand plans to make the drug available in the second half of 2024.

Ligand计划在2024年下半年推出该药物。