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
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.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.
美国FDA周三批准了维罗纳制药（NASDAQ:VRNA）的奥托维亚雷（ensifentrine），用于成人慢性阻塞性肺疾病（COPD）的维持治疗。
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
奥托维亚雷是一种具有新机制作用的吸入性产品，用于COPD的维持治疗，已有20多年时间没有出现过。
Related: Verona Pharma's Promising COPD Treatment Puts It in GSK's Acquisition Crosshairs, Analysts Predict Big Moves.
相关新闻: 吉利德的 Trodelvy 在普通膀胱癌最常见类型的后期研究中未能达到主要目标。维罗纳制药的有望治疗COPD的药品令其成为赛诺菲安万特的收购目标，分析师预测会出现重大变化。
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.
奥托维亚雷是第一种选择性磷酸二酯酶3和磷酸二酯酶4（PDE3和PDE4）的双重抑制剂，结合了支气管扩张剂和非甾体抗炎药效应于一体的分子。
Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without requiring high inspiratory flow rates or complex hand-breath coordination.
奥托维亚雷通过标准射流雾化器直接送达肺部，无需特别高的吸气流量或复杂的手-口协调。
The US approval of Ohtuvayre was based on extensive data, including the Phase 3 ENHANCE trials.
美国批准奥托维亚雷的依据是广泛的数据，包括第三阶段的ENHANCE试验。
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试验中，奥托维亚雷单独应用或与其他维持治疗药物联合使用均显示出治疗效益，并且在中重度COPD受试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.
公司表示已经预备充分，将通过专业药房独家网络在2024年第三季度推出奥托维亚雷。
"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分析师告诉路透社：“医生们非常兴奋，因为这种药非常安全，并且可以帮助患者在一定程度上呼吸”。
Reuters report added the drug could generate $3.6 billion in peak sales.
路透社的报道称，这种药品可能会带来36亿美元的销售额。
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.
引用首席商业官Christopher Martin的话，路透社突出了“该公司预计将拥有大约100名销售代表，以接触约15,000名医生，并且如果获得批准，就非常有利于执行该计划”。
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，美国FDA扩展了对赛诺菲（NASDAQ:SNY）和再生元医药（NASDAQ:REGN）的杜蒙玄（dupilumab）优先审查补充申请的目标行动日期，以作为特定成人患者未受控制的慢性阻塞性肺疾病（COPD）的附加维持治疗。这种肺病通常由吸烟引起。
The revised target action date is September 27, 2024.
新的目标行动日期是2024年9月27日。
Price Action: At last check on Thursday, VRNA shares were up 2.38% at $15.04.
股价表现：截至上周四收盘，VRNA股价上涨2.38％，至15.04美元。
Photo by voronaman via Shutterstock
照片由Shutterstock的voronaman提供
