FDA Approves Regeneron/Sanofi's Blockbuster Dupixent For Smoker's Lung Disease
FDA Approves Regeneron/Sanofi's Blockbuster Dupixent For Smoker's Lung Disease
The FDA approval is based on data from two Phase 3 trials (BOREAS and NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy).On Friday, the FDA approved Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi SA's (NASDAQ:SNY) Dupixent (dupilumab) as an add-on maintenance treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, generally known as "smoker's lung."
上週五，美國食品和藥物管理局批准了再生元製藥公司（納斯達克：REGN）和賽諾菲安萬特公司（納斯達克：SNY）的杜哌替溼信（dupilumab），作爲未受控制的慢性阻塞性肺病（COPD）和嗜酸性表型的附加維持治療，通常被稱爲"吸菸者的肺。"
Dupixent is the first biologic medicine approved in the U.S. to treat these patients.
杜哌替溼信是在美國獲批治療這些患者的第一種生物製劑藥物。
Also Read: Sanofi, Regeneron Drug Dupixent Shows Successful Treatment Of Patients With Inflammatory Skin Disease.
另請閱讀：賽諾菲、再生元製藥公司的藥物杜哌替溼信展示了成功治療患有炎症性皮膚病的患者。
The FDA approval is based on data from two Phase 3 trials (BOREAS and NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy).
FDA的批准基於來自兩項第3期試驗（BOREAS和NOTUS）的數據，評估了與安慰劑相比，杜哌替溼信在已接受最大標準療法吸入治療的成年人中的療效和安全性（幾乎都在三聯療法上）。
- Patients who received Dupixent in BOREAS (n=468) and NOTUS (n=470) experienced the following outcomes, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):
- The primary endpoint is a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks.
- 74mL and 68mL numerically greater improvements in post-bronchodilator FEV1 from baseline at week 12 compared to placebo, sustained at 52 weeks. Statistically significant improvements of similar magnitude were observed in pre-bronchodilator FEV1 from baseline at 12 and 52 weeks, a key secondary endpoint.
- 51% response in a health-related quality of life measure in both trials compared to 43% and 47% with placebo at 52 weeks.
- 在BOREAS（n=468）和NOTUS（n=470）中接受了杜哌替溼信治療的患者分別與接受安慰劑的患者（BOREAS n=471；NOTUS n=465）相比，經歷了以下結果：
- 主要終點是在52周內減少中度或重度COPD惡化年化發病率30%和34%。
- 相較於安慰劑，BOREAS和NOTUS在12周時吸入支氣管擴張劑後1秒用力呼氣容積（FEV1）分別較基線改善了74毫升和68毫升，並在52周保持。在12周和52周時，基線前用力呼氣容積（FEV1）也觀察到類似幅度的顯著改善，這是一個關鍵的次要終點。
- 在52周時，兩項試驗中有51%的患者在與安慰劑相比的健康相關生活質量措施中有反應，而安慰劑組分別爲43%和47%。
About half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy.
儘管接受三聯吸入治療，約一半的COPD患者仍然會出現加劇。
In the U.S., approximately 300,000 people live with inadequately controlled COPD and an eosinophilic phenotype.
在美國，約有大約300,000人生活在控制不佳的COPD和嗜麟足癖表型。
Patients with an eosinophilic phenotype contribute to a ~30% increase in exacerbations and an increased risk of COPD-related re-hospitalizations within a year.
患有嗜麟足癖表型的患者會導致加劇增加約30%，並增加一年內與COPD相關再次入院的風險。
Today, China's National Medical Products Administration also approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease characterized by raised blood eosinophils.
今天，中國國家醫藥監督管理局還批准了Dupixent（dupilumab）作爲成人慢性阻塞性肺疾病控制不佳的附加維持治療，表現爲血液嗜麟足癖升高。
The approval is based on BOREAS and NOTUS Phase 3 trial results.
批准是基於BOREAS和NOTUS第3期試驗結果。
Price Action: At last check Friday, REGN stock was up 2.86% at $1,069.75, and SNY stock was up 1.49% at $57.85.
股價走勢：截至上週五最後交易時，REGN股價上漲2.86%，報1069.75美元，而SNY股價上漲1.49%，報57.85美元。
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譯文內容由第三人軟體翻譯。
