First Inhaled COPD Therapy In Over 2 Decades - FDA Approves Verona Pharma's First Commercial Product
First Inhaled COPD Therapy In Over 2 Decades - FDA Approves Verona Pharma's First Commercial Product
On Wednesday, the FDA approved Verona Pharma plc's (NASDAQ:VRNA) Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
美國FDA週三批准了維羅納製藥（NASDAQ:VRNA）的奧托維亞雷（ensifentrine），用於成人慢性阻塞性肺疾病（COPD）的維持治療。
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
奧托維亞雷是一種具有新機制作用的吸入性產品，用於COPD的維持治療，已有20多年時間沒有出現過。
Related: Verona Pharma's Promising COPD Treatment Puts It in GSK's Acquisition Crosshairs, Analysts Predict Big Moves.
相關新聞: 吉利德的 Trodelvy 在普通膀胱癌最常見類型的後期研究中未能達到主要目標。維羅納製藥的有望治療COPD的藥品令其成爲賽諾菲安萬特的收購目標，分析師預測會出現重大變化。
Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (PDE3 and PDE4) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule.
奧托維亞雷是第一種選擇性磷酸二酯酶3和磷酸二酯酶4（PDE3和PDE4）的雙重抑制劑，結合了支氣管擴張劑和非甾體抗炎藥效應於一體的分子。
Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without requiring high inspiratory flow rates or complex hand-breath coordination.
奧托維亞雷通過標準射流霧化器直接送達肺部，無需特別高的吸氣流量或複雜的手-口協調。
The US approval of Ohtuvayre was based on extensive data, including the Phase 3 ENHANCE trials.
美國批准奧托維亞雷的依據是廣泛的數據，包括第三階段的ENHANCE試驗。
In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD.
在ENHANCE試驗中，奧托維亞雷單獨應用或與其他維持治療藥物聯合使用均顯示出治療效益，並且在中重度COPD受試者中具有良好的耐受性。
The company says it is fully staffed to launch and expects Ohtuvayre to be available in the third quarter of 2024 through an exclusive network of specialty pharmacies.
公司表示已經預備充分，將通過專業藥房獨家網絡在2024年第三季度推出奧托維亞雷。
"Physicians are wildly excited about this drug because it is very safe, and it helps patients breathe to a measurable extent," a BTIG analyst told Reuters.
一位BTIG分析師告訴路透社：“醫生們非常興奮，因爲這種藥非常安全，並且可以幫助患者在一定程度上呼吸”。
Reuters report added the drug could generate $3.6 billion in peak sales.
路透社的報道稱，這種藥品可能會帶來36億美元的銷售額。
Citing Chief Commercial Officer Christopher Martin, Reuters highlighted, "The company expects to have around 100 sales representatives to reach about 15,000 physicians and is "in a very good position to execute on that" if it gets approval.
引用首席商業官Christopher Martin的話，路透社突出了“該公司預計將擁有大約100名銷售代表，以接觸約15,000名醫生，並且如果獲得批准，就非常有利於執行該計劃”。
Most recently, the FDA extended the target action date of priority review of supplemental application seeking approval for Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceutical Inc's (NASDAQ:REGN) Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD), a lung disease usually caused by smoking.
最近，美國FDA擴展了對賽諾菲（NASDAQ:SNY）和再生元醫藥（NASDAQ:REGN）的杜蒙玄（dupilumab）優先審查補充申請的目標行動日期，以作爲特定成人患者未受控制的慢性阻塞性肺疾病（COPD）的附加維持治療。這種肺病通常由吸菸引起。
The revised target action date is September 27, 2024.
新的目標行動日期是2024年9月27日。
Price Action: At last check on Thursday, VRNA shares were up 2.38% at $15.04.
股價表現：截至上週四收盤，VRNA股價上漲2.38％，至15.04美元。
Photo by voronaman via Shutterstock
照片由Shutterstock的voronaman提供
譯文內容由第三人軟體翻譯。