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.
周三，欧洲药品管理局（EMA）批准杜珀单抗（Dupixent ）作为附加维护治疗方案，用于成年患有未控制的慢性阻塞性肺病（COPD）并伴有高血液嗜酸性粒细胞的患者。
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.
具体而言，批准涵盖已经接受组合治疗的患者，包括一种吸入型皮质类固醇（ICS）、一种长效β2-受体激动剂（LABA）和一种长效毒蕈碱受体拮抗剂（LAMA）或一种LABA和LAMA的组合，如果不适合使用ICS的话。
Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) are jointly developing dupilumab under a global collaboration agreement.
赛诺菲安万特公司（NASDAQ：SNY）和再生元制药公司（NASDAQ：REGN）正在全球合作开发Dupixent。
The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients.
EMA是全球首个批准Dupixent治疗COPD患者的监管机构。
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领域十多年来的首个新治疗方法，对欧盟约22万成年患者提供了新的治疗选择。
The approval represents the sixth approved indication for Dupixent in the EU and the seventh approved indication globally.
批准为Dupixent在欧盟的第六种治疗适应症，并在全球获得第七种治疗适应症。
The approval is based on results from the landmark phase 3 BOREAS and NOTUS studies.
批准基于重要的III期BOREAS和NOTUS研究结果。
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):
在疗效方面，与安慰剂（BOREAS n=471；NOTUS n=465）相比，BOREAS（n=468）和NOTUS（n=470）的Dupixent患者分别在52周内经历以下情况：
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急性加重的年化发作率减少30％和34％，这是主要终点。
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.
与基线相比，12周时呼气前胸片容积（FEV1）分别增加160 mL和139 mL，相比之下，安慰剂组分别为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.
这些改善在2周和4周时即可观察到，并在两个研究中均持续52周。
Improvements in health-related quality of life (statistically significant in BOREAS and nominally significant in NOTUS)
健康相关生命质量方面的改善（在BOREAS中具有统计学显著性，在NOTUS中名义上具有显著性）
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.
对于起始时高于等于20ppb的基线呼出气一氧化氮（一种气道炎症生物标志物）的患者，Dupixent对比安慰剂的减少加重发作和改善肺功能也得到了观察。
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扩展了该产品的目标行动日期，审查了Dupixent（dupilumab）作为治疗控制不佳的肺气肿(COPD)成年患者的附加维持治疗的补充申请，目标行动日期为9月27日。
The FDA requested additional efficacy analyses on Dupixent's efficacy in the BOREAS and NOTUS pivotal trials.
FDA要求对Dupixent在BOREAS和NOTUS关键试验中的疗效进行进一步的效能分析。
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.
股票走势：周三，再生元制药公司REGN的股票盘前上涨0.16％至1046.28美元，赛诺菲SA（SNY）的股票盘前上涨0.31％至48.69美元。
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