Europe Approves Sanofi/Regeneron's Dupixent for 'Smoker's Lungs' A Month After US FDA Asks For Data
Europe Approves Sanofi/Regeneron's Dupixent for 'Smoker's Lungs' A Month After US FDA Asks For Data
On Wednesday, the European Medicines Agency (EMA) approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
週三，歐洲藥品管理局（EMA）批准杜珀單抗（Dupixent ）作爲附加維護治療方案，用於成年患有未控制的慢性阻塞性肺病（COPD）並伴有高血液嗜酸性粒細胞的患者。
Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) or on a combination of LABA and LAMA if ICS is not appropriate.
具體而言，批准涵蓋已經接受組合治療的患者，包括一種吸入型皮質類固醇（ICS）、一種長效β2-受體激動劑（LABA）和一種長效毒蕈鹼受體拮抗劑（LAMA）或一種LABA和LAMA的組合，如果不適合使用ICS的話。
Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) are jointly developing dupilumab under a global collaboration agreement.
賽諾菲安萬特公司（NASDAQ：SNY）和再生元製藥公司（NASDAQ：REGN）正在全球合作開發Dupixent。
The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients.
EMA是全球首個批准Dupixent治療COPD患者的監管機構。
Dupixent is the first new treatment approach for COPD in more than a decade and a new option for approximately 220,000 adults in the EU.
Dupixent是COPD領域十多年來的首個新治療方法，對歐盟約22萬成年患者提供了新的治療選擇。
The approval represents the sixth approved indication for Dupixent in the EU and the seventh approved indication globally.
批准爲Dupixent在歐盟的第六種治療適應症，並在全球獲得第七種治療適應症。
The approval is based on results from the landmark phase 3 BOREAS and NOTUS studies.
批准基於重要的III期BOREAS和NOTUS研究結果。
In terms of efficacy, Dupixent patients in BOREAS (n=468) and NOTUS (n=470) experienced the following, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):
在療效方面，與安慰劑（BOREAS n=471；NOTUS n=465）相比，BOREAS（n=468）和NOTUS（n=470）的Dupixent患者分別在52周內經歷以下情況：
30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks-the primary endpoint.
中度或重度COPD急性加重的年化發作率減少30％和34％，這是主要終點。
Improvements in lung function (pre-bronchodilator FEV1) from baseline by 160 mL and 139 mL at 12 weeks compared to 77 mL and 57 mL.
與基線相比，12周時呼氣前胸片容積（FEV1）分別增加160 mL和139 mL，相比之下，安慰劑組分別爲77 mL和57 mL。
These improvements were observed as early as weeks 2 and 4 and were sustained at 52 weeks in both studies.
這些改善在2周和4周時即可觀察到，並在兩個研究中均持續52周。
Improvements in health-related quality of life (statistically significant in BOREAS and nominally significant in NOTUS)
健康相關生命質量方面的改善（在BOREAS中具有統計學顯著性，在NOTUS中名義上具有顯著性）
Reductions in exacerbations and improved lung function for Dupixent versus placebo were also observed in patients with higher baseline fractional exhaled nitric oxide (≥20ppb) – an airway biomarker of inflammation.
對於起始時高於等於20ppb的基線呼出氣一氧化氮（一種氣道炎症生物標誌物）的患者，Dupixent對比安慰劑的減少加重發作和改善肺功能也得到了觀察。
In May, the FDA extended the target action date of priority review of supplemental application seeking approval for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled COPD, a lung disease that's usually caused by smoking, with a target action date of September 27.
今年5月，FDA擴展了該產品的目標行動日期，審查了Dupixent（dupilumab）作爲治療控制不佳的肺氣腫(COPD)成年患者的附加維持治療的補充申請，目標行動日期爲9月27日。
The FDA requested additional efficacy analyses on Dupixent's efficacy in the BOREAS and NOTUS pivotal trials.
FDA要求對Dupixent在BOREAS和NOTUS關鍵試驗中的療效進行進一步的效能分析。
Price Action: REGN shares were trading higher by 0.16% at $1,046.28 premarket session at last check Wednesday. SNY shares were up 0.31% at $48.69.
股票走勢：週三，再生元製藥公司REGN的股票盤前上漲0.16％至1046.28美元，賽諾菲SA（SNY）的股票盤前上漲0.31％至48.69美元。
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譯文內容由第三人軟體翻譯。