FDA Approves UCB's Psoriasis Drug For Expanded Use In Painful Inflammatory Skin Disease
FDA Approves UCB's Psoriasis Drug For Expanded Use In Painful Inflammatory Skin Disease
Hidradenitis suppurativa is a chronic inflammatory skin disease.On Wednesday, the FDA approved UCB SA's (OTC:UCBJY) (OTC:UCBJF) Bimzelx (bimekizumab-bkzx) for adults with moderate to severe hidradenitis suppurativa (HS).
周三，美国食品药品监督管理局（FDA）批准了UCb SA的（场外交易：UCBJY）的（场外交易：UCBJF）Bimzelx（bimekizumab-bkzx）用于治疗中重度腺样囊肿性汗腺炎（HS）的成年人。
Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).
Bimekizumab-bkzx是首个也是唯一一个获批的药物，旨在选择性抑制白细胞介素17F (IL-17F)以及白细胞介素17A (IL-17A)。
Also Read: Belgium-Based Pharma Firm UCB To Offload China Neurology, Allergy Business For $680M To Asset Management Companies
另请参阅：总部位于比利时的制药公司UCb将以68000万美元的价格将中国的神经学和过敏业务出售给资产管理公司。
Hidradenitis suppurativa is a chronic inflammatory skin disease.
脓肿性汗腺炎是一种慢性炎症性皮肤疾病。
The main symptoms are nodules, abscesses, and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin, and buttocks.
主要症状包括结节、脓肿和流脓的瘘管，即引导皮肤之外的通道，通常位于腋下、腹股沟和臀部。
Data from two Phase 3 studies, BE HEARD I and BE HEARD II, support the approval.
来自两项第三阶段研究BE HEARD I和BE HEARD II的数据支持了该药物的批准。
Results showed that a higher proportion of patients treated with bimekizumab-bkzx vs. placebo achieved a 50% or greater improvement in signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials.
结果显示，与安慰剂相比，接受bimekizumab-bkzx治疗的患者在第16周达到50%或更大改善的比例更高，改善的指标由HiSCR50衡量，这是两项试验的主要终点。
Bimekizumab-bkzx treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16. Clinical responses were sustained to Week 48.
bimekizumab-bkzx治疗在第16周也在关键次要终点HiSCR75上与安慰剂相比产生了临床上有意义的改善。临床反应持续到第48周。
This FDA approval of bimekizumab-bkzx for adults with moderate to severe hidradenitis suppurativa follows its recent approvals for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis.
美国FDA批准bimekizumab-bkzx用于中重度汗腺脓肿成年人，这一批准紧随其对治疗活跃性牛皮癣关节炎的成年人、活跃性非放射性轴性脊柱关节炎具有客观炎症迹象的成年人以及活跃性强直性脊柱炎的成年人的近期批准之后。
Bimekizumab-bkzx was first approved in the U.S. in October 2023 for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
bimekizumab-bkzx于2023年10月首次在美国获得批准，用于中重度斑块型牛皮癣的成年人，适合系统治疗或光疗的患者。
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Image via Adobe Stock
来源于adobe Stock
