Pictured: Woman scratching skin lesions on her elbow/iStock, helivideo

图：helivideo女性在肘部/肘部刮擦皮肤病变

The FDA on Wednesday approved UCB’s bimekizumab for the treatment of adults with moderate-to-severe plaque psoriasis. The treatment will be sold under the brand name Bimzelx.

美国食品及药物管理局周三批准UCB的bimekizumab用于治疗中度至重度斑块状银屑病的成人。治疗将以Bimzelx品牌销售。

Bimzelx is a humanized IgG1 monoclonal antibody that works by targeting IL-17A and IL-17F, both central players in the inflammatory cascade. Bimzelx is the first FDA-approved plaque psoriasis medication that inhibits both cytokines, according to UCB’s announcement.

Bimzelx是一种人源化IgG1单克隆抗体，通过靶向IL-17A和IL-17F起作用，IL-17A和IL-17F都是炎症级联反应的中心参与者。根据UCB的公告，Bimzelx是第一个FDA批准的抑制两种细胞因子的斑块状银屑病药物。

“We know that completely clear skin is valued by people with psoriasis,” Emmanuel Caeymaex, executive vice president of immunology solutions at UCB, said in a statement, adding that the approval of Bimzelx can help raise the standard of care for this condition.

UCB免疫学解决方案执行副总裁Emmanuel Caeymaex在一份声明中说：“我们知道牛皮癣患者对完全透明的皮肤很有价值，他补充说，Bimzelx的批准可以帮助提高这种情况的护理标准。

“With BIMZELX now approved for psoriasis, we will move forward rapidly to submit applications for additional indications in the U.S.,” Caeymaex said.

“随着BIMZELX现在被批准用于牛皮癣，我们将迅速向前提交申请在美国的其他适应症，”Caeymaex说。

Bimzelx is administered using a single-dose 160-mg/mL prefilled syringe or autoinjector, and its approval covers adult patients who are also candidates for systematic therapy or phototherapy. Its label does not carry a boxed warning but does have precautions against suicidal ideation and behavior, infections, inflammatory bowel disease, tuberculosis and abnormalities in liver biochemistry..

Bimzelx使用单剂量160 mg/mL预充式注射器或自动注射器进行给药，其批准涵盖也是系统治疗或光疗候选者的成年患者。它的标签没有盒装警告，但确实有预防自杀意念和行为，感染，炎症性肠病，肺结核和肝脏生物化学异常的措施。。

UCB backed its FDA application with data from three Phase III studies. The first, dubbed BE VIVID, compared Bimzelx with placebo and J&J’s Stelara (ustekinumab). Meanwhile, the BE READY trial used placebo as a comparator, while the BE SURE trial pit Bimzelx against AbbVie’s Humira (adalimumab).

UCB利用三项III期研究的数据支持其FDA申请。第一个被称为生动，将Bimzelx与安慰剂和J＆J的Stelara（ustekinumab）进行了比较。与此同时，BE-READY试验使用安慰剂作为对照，而BE-SURE试验使用Bimzelx对抗AbbVie的Humira（阿达木单抗）。

Taken together, data from these three studies showed that Bimzelx can induce greater levels of skin clearance than placebo, Stelara and Humira. In particular, more than 80% of treated patients achieved clear or almost clear skin, as defined by at least a 90% improvement in the Psoriasis Area & Severity Index (PASI)..

总之，这三项研究的数据显示，与安慰剂，Stelara和Humira相比，Bimzelx可以诱导更高水平的皮肤清除率。特别是，超过80%的治疗患者皮肤清晰或几乎透明，银屑病面积和严重程度指数（PASI）至少改善90%。。

Complete skin clearance, defined by a 100% improvement in PASI, was observed in around 60% of patients treated with Bimzelx.

在约60%接受Bimzelx治疗的患者中观察到完全皮肤清除（由PASI改善100%定义）。

Wednesday’s approval is the culmination of a long and somewhat rough regulatory road for Bimzelx. In October 2021, UCB reported that the FDA needed to delay its verdict on the antibody’s Biologics License Application because the regulator was unable to conduct on-site facility inspections due to coronavirus-related travel restrictions..

星期三的批准是Bimzelx漫长而有些粗糙的监管道路的高潮。2021年10月，UCB报告说，FDA需要推迟对抗体生物制剂许可证申请的判决，因为由于冠状病毒相关的旅行限制，监管机构无法进行现场设施检查。。

In May 2022, the delay ended in a Complete Response Letter, with the FDA pointing to “pre-approval inspection observations” that the company needed to address before the application can be reconsidered.

在2022年5月，延误以一封完整的回复信结束，FDA指出公司在重新考虑申请之前需要解决的“批准前检查意见”。

Bimzelx’s approval is UCB’s second regulatory win this week. The biopharma company won another FDA nod on Tuesday for its subcutaneous C5 complement inhibitor zilucoplan, now marketed as Zilbrysq, for generalized myasthenia gravis.

Bimzelx的批准是UCB本周的第二次监管胜利。biopharma公司在星期二因其皮下C5补体抑制剂zilucoplan（现以Zilbrysq销售）获得另一个FDA点头，用于广泛性重症肌无力。

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Tristan Manalac是位于菲律宾大马尼拉的独立科学作家。他可以联系到tristan@tristanmanalac.com或者tristan.manalac@biospace.com.