FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
On Friday, the FDA accepted for review the resubmission of the supplemental biologics license application (sBLA) for Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi SA's (NASDAQ:SNY) Dupixent (dupilumab) for patients ages 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.
週五，FDA接受了再生元製藥公司（納斯達克：REGN）和賽諾菲安萬特（納斯達克：SNY）的Dupixent（dupilumab）的補充生物製品許可證申請（sBLA）的重新提交，針對12歲及以上的慢性自發性蕁麻疹（CSU）患者，其疾病未能在H1抗組胺治療中得到有效控制。
The target action date for the FDA decision is April 18, 2025.
FDA決定的目標行動日期爲2025年4月18日。
Data from the multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU support the resubmitted supplemental marketing.
來自多項研究的LIBERTY-CUPID III期臨床項目（研究A、研究B和研究C）針對Dupixent在CSU中的數據支持了重新提交的補充市場申請。
Also Read: Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease
另請閱讀：再生元/賽諾菲的Dupixent批准標誌着吸菸者肺病治療的重大突破。
Earlier this year, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A.
今年早些時候，日本成爲全球第一個批准並推出Dupixent用於成人和青少年CSU患者的國家，基於研究A的結果。
The supplemental marketing adds results from Study C, conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal study in biologic-naïve patients, met its primary and key secondary endpoints, confirming the results of the previous Study A.
補充市場申請增加了研究C的結果，該研究在接受標準治療抗組胺藥的無法控制的CSU患者中進行。研究C是生物製品未曾接觸患者的第二個LIBERTY-CUPID關鍵研究，達到了其主要和關鍵次要終點，確認了之前研究A的結果。
Results showed that Dupixent significantly reduced itch and urticaria activity (itch and hives).
結果顯示，Dupixent顯著減少了瘙癢和蕁麻疹活動（瘙癢和風團）。
In March 2023, the FDA accepted the supplemental marketing application for Dupixent (dupilumab) to treat adults and adolescents with chronic spontaneous urticaria, with the target action date for the FDA decision of October 22, 2023.
在2023年3月，FDA接受了Dupixent（dupilumab）的補充市場申請，以治療成人和青少年慢性自發性蕁麻疹，FDA決定的目標行動日期爲2023年10月22日。
In October 2023, the FDA issued a Complete Response Letter for the supplemental Biologics License Application and stated that additional efficacy data are required to support approval.
在2023年10月，FDA針對補充生物製品許可證申請發出了完整回應函，並表示需要額外的有效性數據以支持批准。
It did not identify any issues with safety or manufacturing.
它沒有發現任何安全性或製造業-半導體方面的問題。
CSU is a chronic inflammatory skin disease driven partly by type-2 inflammation, which causes sudden hives and recurring itch.
慢性自發性蕁麻疹（CSU）是一種慢性炎症性皮膚疾病，部分由2型炎症驅動，導致突然出現蕁麻疹和反覆瘙癢。
CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control urticaria symptoms.
慢性自發性蕁麻疹通常使用H1抗組胺藥物治療，這些藥物靶向細胞上的H1受體以控制蕁麻疹症狀。
More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.
美國有超過30萬人患有未能通過抗組胺藥物有效控制的CSU。
Price Action: REGN stock closed at $782.51 on Thursday, and SNY stock is up 1.09% at $48.34 during the premarket session at last check Friday.
價格動態：再生元製藥公司（REGN）股票週四收於782.51美元，賽諾菲安萬特（SNY）股票在週五最後一次檢查時在盤前交易時上漲1.09%，達到48.34美元。
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Photo: Shutterstock
Photo: shutterstock
譯文內容由第三人軟體翻譯。
