▎藥明康德/報道今日，艾伯維（AbbVie）公司宣布，F(xiàn)DA批準(zhǔn)其開發(fā)的IL-23特異性抑制劑Skyrizi（risankizumab）上市，用于治療中重度銀屑病患者。這些患者適用于使用全身性療法或者光療法。在臨床試驗中，Skyrizi能夠高度清除皮膚癥狀，大多數(shù)（>80%）接受治療的患者接受治療一年后90%皮膚癥狀消失（PASI 90），超過半數(shù)患者皮膚癥狀完全消失（PASI 100）。 銀屑病又稱為牛皮癬，是一種不會傳染的炎癥性疾病?；颊叩钠つw上出現(xiàn)發(fā)炎的鱗狀皮膚增生，通常帶來嚴(yán)重瘙癢和刺痛。銀屑病患者可能患上多種相關(guān)疾病，例如，全球高達30%的銀屑病患者可能患上銀屑病關(guān)節(jié)炎。這是一種慢性炎癥性疾病，導(dǎo)致無法逆轉(zhuǎn)的關(guān)節(jié)變形和殘疾。最新的科學(xué)研究指出，IL-23/IL-17信號通路在介導(dǎo)銀屑病和其它慢性免疫疾病方面起到關(guān)鍵性作用，這一通路也成為創(chuàng)新療法開發(fā)的重要靶標(biāo)。 Skyrizi是艾伯維和勃林格殷格翰（Boehringer Ingelheim）共同開發(fā)的潛在重磅抗炎癥藥物。它是一款靶向IL-23的人源化單克隆抗體，通過與IL-23的p19亞基相結(jié)合，能夠有選擇性地阻斷IL-23信號通路。這款新藥日前剛剛被科睿唯安列為2019年最值得關(guān)注的上市新藥之一，認(rèn)為它可能在2023年之前成為重磅藥物。 Skyrizi的批準(zhǔn)是基于艾伯維開展的全球性銀屑病臨床項目，包括4項3期臨床試驗。
“Skyrizi獲批對于尋找高度并持久清除皮膚癥狀的銀屑病患者來說，是一個重要的進步，”艾伯維公司總裁Michael Severino博士說：“Skyrizi延續(xù)了艾伯維在免疫學(xué)方面的傳統(tǒng)，擴展本公司的藥物組合，幫助解決銀屑病患者的醫(yī)療需求，體現(xiàn)了我們追求創(chuàng)新療法，改善免疫疾病患者生活的宗旨?！?/p> 參考資料： [1] AbbVie Announces First Regulatory Approval of SKYRIZI? (risankizumab) for the Treatment of Plaque Psoriasis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis and Psoriatic Arthritis in Japan. Retrieved April 21, 2019, from https://news./news/abbvie-announces-first-regulatory-approval-skyrizi-risankizumab-for-treatment-plaque-psoriasis-generalized-pustular-psoriasis-and-erythrodermic-psoriasis-and-psoriatic-arthritis-in-japan.htm [2] AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis. Retrieved April 21, 2019, from https://news./news/abbvie-submits-biologics-license-application-to-us-fda-for-investigational-treatment-risankizumab-for-moderate-to-severe-plaque-psoriasis.htm [3] AbbVie’s risankizumab has uptake caveats despite anticipated approvals. Retrieved April 21, 2019, from https://www./comment/abbvies-risankizumab-uptake-caveats-despite-anticipated-approvals/ [4] AbbVie gets its first approval for a drug execs believe could be worth up to $5B in annual sales. Retrieved April 21, 2019, from https:///abbvie-gets-its-first-approval-for-a-drug-execs-believe-could-be-worth-up-to-5b-in-annual-sales/ [5] Hawkes, et al., (2019). Discovery of the IL-23/IL-17 Signaling Pathway and the Treatment of Psoriasis. The Journal of Immunology. https:///10.4049/jimmunol.1800013 [6] AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI? (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis. Retrieved April 23, 2019, from https://news./news/press-releases/abbvie-expands-immunology-portfolio-in-us-with-fda-approval-skyrizi-risankizumab-rzaa-for-moderate-to-severe-plaque-psoriasis.htm |
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