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).
週三，美國食品藥品監督管理局（FDA）批准了UCb SA的（場外交易：UCBJY）的（場外交易：UCBJF）Bimzelx（bimekizumab-bkzx）用於治療中重度腺樣囊腫性汗腺炎（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是第一種也是唯一一種被批准的藥物，旨在選擇性抑制白細胞介素17F（IL-17F）以及白細胞介素17A（IL-17A）。
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另請參閱：總部位於比利時的製藥公司UCb將以68000萬美元的價格將中國的神經學和過敏業務出售給資產管理公司。
Hidradenitis suppurativa is a chronic inflammatory skin disease.
腺樣囊腫性汗腺炎是一種慢性炎症性皮膚疾病。
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.
主要症狀包括結節、膿腫和排膿的瘻管，即通向皮膚外的通道，通常在腋窩、腹股溝和臀部。
Data from two Phase 3 studies, BE HEARD I and BE HEARD II, support the approval.
來自兩項3期研究BE HEARD I和BE HEARD II的數據支持批准。
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.
結果顯示，與安慰劑相比，使用bimekizumab-bkzx治療的患者在第16周時在HiSCR50評分中達到50%或更高療效改善的比例更高，這是兩項試驗中的主要終點。
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治療還導致主要的排名次要終點HiSCR75在第16周時比安慰劑有臨床意義的改善。臨床反應持續到第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.
bimekizumab-bkzx獲得FDA批准，用於治療中度至重度的汗腺炎性膿腫的成年人，此前已獲批用於治療有活動性銀屑病性關節炎的成年人，有客觀炎症徵象且有活動性非放射性軸突關節病的成年人，以及有活動性強直性脊椎炎的成年人。
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首次於2023年10月在美國獲得批准，用於治療有中度至重度斑塊型銀屑病且適合接受全身治療或光療的成年人。
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Image via Adobe Stock
來源於adobe Stock
譯文內容由第三人軟體翻譯。
